Label: MEDIQUE APAP EXTRA STRENGTH ACETAMINOPHEN TABLET, FILM COATED tablet, film coated
- NDC Code(s): 51662-1274-2
- Packager: HF Acquisition Co LLC, DBA HealthFirst
- This is a repackaged label.
- Source NDC Code(s): 47682-175
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 2, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
more than 4,000 mg in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this productAllergy alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
skin reddening
blisters
rashIf a skin reaction occurs, stop use and seek medical help right away.
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
-
STOP USE
Stop use and ask a doctor if
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
new symptoms occur
redness or swelling is presentThese 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:
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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DOSAGE & ADMINISTRATION
Directions
do not use more than directed (see overdose warning)
Adults and children: (12 years and over)take 2 tablets every 6 hours while symptoms last.
do not take more than 6 tablets in 24 hours, unless directed by a doctor
do not use for more than 10 days unless directed by a doctorChildren under 12 years: Ask a doctor
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MEDIQUE APAP EXTRA STRENGTH ACETAMINOPHEN TABLET, FILM COATED
medique apap extra strength acetaminophen tablet, film coated tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51662-1274(NDC:47682-175) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) HYPROMELLOSES (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code AZ;235 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51662-1274-2 2 in 1 PACKET; Type 0: Not a Combination Product 01/02/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 01/02/2024 Labeler - HF Acquisition Co LLC, DBA HealthFirst (045657305) Registrant - HF Acquisition Co LLC, DBA HealthFirst (045657305) Establishment Name Address ID/FEI Business Operations HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel(51662-1274)