EXTRA STRENGTH PAIN RELIEF- acetaminophen tablet, film coated

Maximum Strength Nighttime Sever Cold and Flu by

Drug Labeling and Warnings

Maximum Strength Nighttime Sever Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Purpose

Pain 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 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 you have liver disease

Ask a doctor or pharmacist before use if you are taking 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 & children 12 years & 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 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?

1-888-333-9792

Principal Display Panel

Compare to Extra Strength Tylenol® Caplets active ingredient†

Extra Strength pain relief

acetaminophen 325 mg - pain reliever / fever reducer

40 Caplets

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEF 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-4211
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	S500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-4211-4	1 in 1 CARTON	08/22/2022
1		40 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	08/22/2022

Labeler - Spirit Pharmaceuticals LLC (179621011)