REGULAR STRENGTH PAIN RELIEVER- acetaminophen tablet, film coated

Regular Strength Pain Reliever by

Drug Labeling and Warnings

Regular Strength Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each tablet) Acetaminophen 325 mg

PurposePain reliever/fever reducer

Uses temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if  adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours which is the maximum daily amount taken with other drugs containing acetaminophen adult has 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 non prescription). 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 a doctor before use if the user hasliver disease

Ask a doctor or pharmacist before use if the user istaking the blood thinning drug warfarin

Stop use and ask a doctor if  pain gets worse or lasts more than 10 days  pain gets worse or lasts more than 5 days in children under 12 years  fever gets worse or lasts 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.

Directions Do not take more than directed (see overdose warning) adults & children 12 years & over: take 2 tablets every 4 to 6 hours while symptoms last                                                   do not take more than 10 tablets in 24 hours, unless directed by a doctor                                                   do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years: take 1 tablet every 4 to 6 hours while symptoms last                                                     do not take more than 5 tablets in 24 hours                                                     do not use for more than 5 days unless directed by a doctor children under 6 years: ask a doctor

Other information store between 20–25°C (68–77°F)

Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, pre-gelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments? 833-358-6431

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INGREDIENTS AND APPEARANCE

REGULAR STRENGTH PAIN RELIEVER 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-1243
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	S99
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-1243-1	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	02/02/2024

Labeler - Strategic Sourcing Services, LLC (116956644)