Panadol Pm
Acetaminophen And Diphenhydramine Hcl
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0135-0608Panadol Pm also known as Acetaminophen And Diphenhydramine Hcl is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Panadol Pm is 0135-0608. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Panadol Pm drug includes Acetaminophen - 500 mg/1 Diphenhydramine Hydrochloride - 25 mg/1 . The currest status of Panadol Pm drug is Active.
Drug Information:
| Drug NDC: | 0135-0608 |
| 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: | Panadol Pm |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Panadol |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | PM |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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 And Diphenhydramine Hcl |
| 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: | Tablet, Film Coated |
| 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 - 500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE - 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 NOT 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 Dec, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| 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: | part343 |
| 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: | 1092189
1094718
|
| 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
TC2D6JAD40
|
| 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: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
|
| 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 |
|---|
| 0135-0608-01 | 1 BOTTLE in 1 CARTON (0135-0608-01) / 24 TABLET, FILM COATED in 1 BOTTLE | 01 Dec, 2016 | N/A | No |
| 0135-0608-02 | 1 BOTTLE in 1 CARTON (0135-0608-02) / 50 TABLET, FILM COATED in 1 BOTTLE | 01 Dec, 2016 | N/A | No |
| 0135-0608-03 | 50 PACKET in 1 CARTON (0135-0608-03) / 2 TABLET, FILM COATED in 1 PACKET (0135-0608-04) | 01 Dec, 2016 | 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 nighttime sleep-aid
Product Elements:
Panadol pm acetaminophen and diphenhydramine hcl acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine carnauba wax crospovidone (120 .mu.m) fd&c blue no. 1 fd&c blue no. 2 hypromellose, unspecified magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polysorbate 80 povidone, unspecified starch, corn sodium starch glycolate type a potato stearic acid titanium dioxide caplet pm
Indications and Usage:
Uses ⢠temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 4,000 mg of acetaminophen in 24 hours ⢠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. do not use ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ⢠with any other product containing diphenhydramine, even one used on skin ⢠in children under 12 years of age ⢠if you are allergic to acetaminophen or any of the inactive ingredients in this product ask a doctor before use if you have ⢠liver disease ⢠glaucoma ⢠a breathing problem such as emphysema o
Read more...r chronic bronchitis ⢠trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if you are taking ⢠the blood thinning drug warfarin ⢠sedatives or tranquilizers when using this product ⢠drowsiness will occur ⢠avoid alcoholic drinks ⢠be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if ⢠sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of a serious underlying medical illness. ⢠pain gets worse or lasts more than 10 days ⢠redness or swelling is present ⢠any new symptoms appear these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning: taking more than the recommended dose can cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick 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 4,000 mg of acetaminophen in 24 hours ⢠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. do not use ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ⢠with any other product containing diphenhydramine, even one used on skin ⢠in children under 12 years of age ⢠if you are allergic to acetaminophen or any of the inactive ingredients in this product ask a doctor before use if you have ⢠liver disease ⢠glaucoma ⢠a breathing problem such as emphysema or chronic bronchitis ⢠trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if you are taking ⢠the blood thinning drug warfarin ⢠sedatives or tranquilizers when using this product ⢠drowsiness will occur ⢠avoid alcoholic drinks ⢠be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if ⢠sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of a serious underlying medical illness. ⢠pain gets worse or lasts more than 10 days ⢠redness or swelling is present ⢠any new symptoms appear these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning: taking more than the recommended dose can cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick 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 ⢠drowsiness will occur ⢠avoid alcoholic drinks ⢠be careful when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions ⢠do not take more than directed (see overdose warning) ⢠adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor ⢠do not give to children under 12 years of age
Stop Use:
Stop use and ask a doctor if ⢠sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of a serious underlying medical illness. ⢠pain gets worse or lasts more than 10 days ⢠redness or swelling is present ⢠any new symptoms appear these could be signs of a serious condition.
Adverse Reactions:
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.
Overdosage:
Overdose warning: taking more than the recommended dose can cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Package Label Principal Display Panel:
Principal display panel ndc 0135-0608-01 panadol extra strength pm acetamnophen pain reliever diphenhydramine hcl nighttime sleep-aid 24 caplets tamper-evident feature: do not use if printed bottle seal (under cap) is missing or broken. read and keep carton for complete information trademarks are owned by or licensed to the gsk group of companies. distributed by: gsk consumer healthcare, warren, nj 07059 ©2016 gsk group of companies or its licensor. 101639xe 101639xe_panadol pm_24 ct.jpg
Further Questions:
Questions or comments? 1-800-455-7139