Robitussin Maximum Strength Severe Multi-symptom 7 In 1 Relief Nighttime
Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0031-8744Robitussin Maximum Strength Severe Multi-symptom 7 In 1 Relief Nighttime also known as Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Robitussin Maximum Strength Severe Multi-symptom 7 In 1 Relief Nighttime is 0031-8744. This drug is available in dosage form of Capsule, Liquid Filled. The names of the active, medicinal ingredients in Robitussin Maximum Strength Severe Multi-symptom 7 In 1 Relief Nighttime drug includes Acetaminophen - 325 mg/1 Dextromethorphan Hydrobromide - 15 mg/1 Doxylamine Succinate - 6.25 mg/1 . The currest status of Robitussin Maximum Strength Severe Multi-symptom 7 In 1 Relief Nighttime drug is Active.
Drug Information:
| Drug NDC: | 0031-8744 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Robitussin Maximum Strength Severe Multi-symptom 7 In 1 Relief Nighttime |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glaxosmithkline Consumer Healthcare Holdings (us) Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule, Liquid Filled |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ACETAMINOPHEN - 325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE - 15 mg/1
DOXYLAMINE SUCCINATE - 6.25 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Jul, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part341 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1094549
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 362O9ITL9D
9D2RTI9KYH
V9BI9B5YI2
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Antihistamine [EPC]
Histamine Receptor Antagonists [MoA]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0031-8744-10 | 5 BLISTER PACK in 1 CARTON (0031-8744-10) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 01 Jul, 2018 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purposes pain reliever/fever reducer cough suppressant antihistamine
Product Elements:
Robitussin maximum strength severe multi-symptom 7 in 1 relief nighttime acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine d&c yellow no. 10 fd&c blue no. 1 gelatin, unspecified glycerin mineral oil polyethylene glycol, unspecified povidone, unspecified propylene glycol water sorbitol r
Indications and Usage:
Uses ⢠temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies: ⢠headache ⢠sore throat ⢠cough ⢠minor aches and pains ⢠runny nose ⢠sneezing ⢠itchy, watery eyes ⢠itching of the nose or throat ⢠temporarily reduces fever
Warnings:
Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 8 capsules in any 24-hour period, which is the maximum daily amount ⢠with other drugs containing acetaminophen ⢠3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: ⢠skin reddening ⢠blisters ⢠rash if a skin reaction occurs, stop use and seek medical help right away. sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use ⢠to sedate a child or to make a child sleepy ⢠if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescr
Read more...iption drug contains an maoi, ask a doctor or pharmacist before taking this product. ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor before use if you have ⢠liver disease ⢠glaucoma ⢠trouble urinating due to an enlarged prostate gland ⢠cough that occurs with too much phlegm (mucus) ⢠a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema ask a doctor or pharmacist before use if you are ⢠taking the blood thinning drug warfarin ⢠taking any other pain reliever/fever reducer ⢠taking sedatives or tranquilizers when using this product ⢠marked drowsiness may occur ⢠avoid alcoholic drinks ⢠alcohol, sedatives, and tranquilizers may increase drowsiness ⢠be careful when driving a motor vehicle or operating machinery ⢠excitability may occur, especially in children stop use and ask a doctor if ⢠pain or cough gets worse or lasts more than 7 days ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. ⢠new symptoms occur if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Do Not Use:
Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 8 capsules in any 24-hour period, which is the maximum daily amount ⢠with other drugs containing acetaminophen ⢠3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: ⢠skin reddening ⢠blisters ⢠rash if a skin reaction occurs, stop use and seek medical help right away. sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use ⢠to sedate a child or to make a child sleepy ⢠if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor before use if you have ⢠liver disease ⢠glaucoma ⢠trouble urinating due to an enlarged prostate gland ⢠cough that occurs with too much phlegm (mucus) ⢠a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema ask a doctor or pharmacist before use if you are ⢠taking the blood thinning drug warfarin ⢠taking any other pain reliever/fever reducer ⢠taking sedatives or tranquilizers when using this product ⢠marked drowsiness may occur ⢠avoid alcoholic drinks ⢠alcohol, sedatives, and tranquilizers may increase drowsiness ⢠be careful when driving a motor vehicle or operating machinery ⢠excitability may occur, especially in children stop use and ask a doctor if ⢠pain or cough gets worse or lasts more than 7 days ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. ⢠new symptoms occur if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
When Using:
When using this product ⢠marked drowsiness may occur ⢠avoid alcoholic drinks ⢠alcohol, sedatives, and tranquilizers may increase drowsiness ⢠be careful when driving a motor vehicle or operating machinery ⢠excitability may occur, especially in children
Dosage and Administration:
Directions ⢠do not take more than 8 capsules in any 24-hour period ⢠do not exceed recommended dosage. taking more than the recommended dose (overdose) may cause serious liver damage. ⢠this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 capsules every 6 hours children under 12 years do not use
Stop Use:
Stop use and ask a doctor if ⢠pain or cough gets worse or lasts more than 7 days ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. ⢠new symptoms occur
Package Label Principal Display Panel:
Principal display panel adult robitussin ® maximum strength severe multi-symptom 7 in 1 relief acetaminophen (pain reliever/fever reducer) dextromethorphan hbr (cough suppressant) doxylamine succinate (antihistamine) cf nighttime max 1. cough, sore throat 2. body aches, fever 3. runny nose, sneezing 4. itchy throat for ages 12 & over 10 liquid-filled capsules robitussin ms s multi sym 10 caps blister pack carton
Further Questions:
Questions or comments? call weekdays from 9 am to 5 pm est at 1 800-762-4675