Label: ACETAMINOPHEN,CAFFEINE AND PYRILAMINE MALEATE tablet
- NDC Code(s): 24689-121-01, 24689-121-02
- Packager: APNAR PHARMA LP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 5, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings:
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 tablets in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy Alert:
Acetaminophen may cause severe skin or severe allergy reactions. Symptoms may include:
- Skin reddening
- blisters
- rash
- hives
- facial swelling
- asthma (wheezing)
- shock
If a skin or general allergic 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.
- If you ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have:
- liver disease
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- you may get drowsy
- avoid alcoholic drinks
- excitability may occur, especially in children
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Stop use and ask a doctor if:
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever get worse or lasts more than 3 days
If pregnant or breast feeding, ask a health care professional before use.
Overdose warning
In case of overdose, get medical help or contact a poison control center 1-800-222-1222 right away. Quick medical help attention is critical for adults as well as children even if you do not notice any signs or symptoms. - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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- INACTIVE INGREDIENT
- QUESTIONS
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN,CAFFEINE AND PYRILAMINE MALEATE
acetaminophen,caffeine and pyrilamine maleate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24689-121 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 60 mg PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 15 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength POVIDONE K30 (UNII: U725QWY32X) WATER (UNII: 059QF0KO0R) MAGNESIUM STEARATE (UNII: 70097M6I30) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSES (UNII: 3NXW29V3WO) Product Characteristics Color white (white to off-white) Score no score Shape OVAL Size 18mm Flavor Imprint Code LT16 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24689-121-01 20 in 1 BOTTLE; Type 0: Not a Combination Product 07/05/2022 2 NDC:24689-121-02 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/05/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/05/2022 Labeler - APNAR PHARMA LP (079568229) Establishment Name Address ID/FEI Business Operations Apnar Pharma Private Limited 876730408 analysis(24689-121) , manufacture(24689-121) Establishment Name Address ID/FEI Business Operations APNAR PHARMA LLP 118530917 pack(24689-121) , label(24689-121)