Label: ACETAMINOPHEN 500 PYRILAMINE MALEATE 15 AND CAFFEINE 60- acetaminophen 500mg pyrilamine maleate 15mg and caffeine 60mg tablets tablet, film coated
- NDC Code(s): 71679-312-00, 71679-312-20
- Packager: Health Pharma USA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 8, 2026
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- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- Uses
-
Warning
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 warning: acetaminophen may cause severe
skin or severe allergic 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
- Ask a doctor before use if you have
-
Ask your doctor or pharmacist before use if you are
ask your 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 appear ■
redness or swelling is present ■ pain gets worse or lasts for
more than 10 days ■ fever gets worse or lasts for more than 3
days 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
(1-800-222-1222) 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 this product
-
Stop use and ask doctor if
Stop use and ask a doctor if:■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be
a symptom of serious underlying medical illness. ■ pain gets worse or lasts more than 10 days ■ fever gets
worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur.
These could be signs of a serious condition. -
If pregnant or breast-feeding
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 (1-800-222-1222) right away.
Prompt medical attention is critical for adults as well as for children even if you do not notice any signs
or symptoms. - Directions
- Other Information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN 500 PYRILAMINE MALEATE 15 AND CAFFEINE 60
acetaminophen 500mg pyrilamine maleate 15mg and caffeine 60mg tablets tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71679-312 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 Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSES (UNII: 3NXW29V3WO) ACETAMINOPHEN (UNII: 362O9ITL9D) 500 mg MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color white Score no score Shape CAPSULE Size 17mm Flavor Imprint Code HH7 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71679-312-00 28500 in 1 BOX; Type 0: Not a Combination Product 03/07/2024 2 NDC:71679-312-20 20 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 03/07/2024 Labeler - Health Pharma USA LLC (080804485) Registrant - Health Pharma USA LLC (080804485)


