EXTRA STRENGTH PAIN RELEIF- acetaminophen tablet, film coated

EXTRA STRENGTH PAIN RELEIF by

Drug Labeling and Warnings

EXTRA STRENGTH PAIN RELEIF 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 caplet) Acetaminophen 500 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 you take  more than 4,000 mg of acetaminophen in 24 hours  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 reddeningblistersrash If a skin 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 are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you haveliver disease

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

Stop use and ask a doctor if pain gets worse or lasts more than 10 days 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 and children 12 years and over:  take 2 caplets every 6 hours while symptoms last                                                           do not take more than 6 caplets 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 information store between 20-25°C (68-77°F)

Inactive ingredients

Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments? 833-358-6431

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELEIF 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-1242
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
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	CAPSULE	Size	18mm
Flavor		Imprint Code	S;500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-1242-1	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)