MEDIQUE APAP EXTRA STRENGTH ACETAMINOPHEN TABLET, FILM COATED tablet, film coated

MEDIQUE APAP EXTRA STRENGTH acetaminophen tablet, film coated by

Drug Labeling and Warnings

MEDIQUE APAP EXTRA STRENGTH acetaminophen tablet, film coated by is a Otc medication manufactured, distributed, or labeled by HF Acquisition Co LLC, DBA HealthFirst. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Acetaminophen 500 mg

PURPOSE

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE

Uses

temporarily relieves minor aches and pains due to:

headache
muscular aches
minor pain of arthritis
backahe
the common cold
toothache
premenstrual and menstrual cramps

temporarily reduces fever

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 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

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 are allergic to acetaminophen or any of the inactive ingredients in this product

ASK DOCTOR

Ask a doctor before use if you have

liver disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if

you are taking the blood thinning drug warfarin

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 present

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:

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.

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 doctor

Children under 12 years: Ask a doctor

OTHER SAFETY INFORMATION

Other information

store at room temperature 59º-86ºF (15º-30ºC)
tamper-evident sealed packets
do not use any opened or torn packets

INACTIVE INGREDIENT

Inactive ingredients

corn starch, hypromellose*, polyethylene glycol*, povidone, pregelatinized corn starch*, sodium starch glycolate*, stearic acid*, titanium dioxide*

*may contain

QUESTIONS

Questions or comments? 1-800-634-7680

KEEP OUT OF REACH OF CHILDREN

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 coated

Product 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)