PAIN RELIEVER EXTRA STRENGTH- acetaminophen capsule, liquid filled

pain reliever by

Drug Labeling and Warnings

pain reliever by is a Otc medication manufactured, distributed, or labeled by Walgreens. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Acetaminophen 500 mg

Purpose

Pain reliever/ fever reducer

Uses

• temporarily relieves minor aches and pains due to

• headache
• the common cold
• 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 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 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 (1-800-222-1222) right away. 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 6 capsules in any 24-hour period
• do not take more than directed (see Overdose warning)
• adults and children 12 years and over
  • take 2 capsules every 6 hours while symptoms  last
  • do not take more than 10 days unless directed by a doctor
• children under 12 years: do not use

Other information

• each capsule contains: sodium 9 mg
• do not chew, crush, or dissolve capsule before swallowing
• store between 15-30ºC (59-86ºF)

Inactive ingredients

FD&C red #40, gelatin, glycerin, polyethylene glycol, potassium hydroxide, povidone, propylene glycol, purified water,sodium hydroxide, sorbitan, sorbitol, titanium dioxide

Questions or comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

EXTRA STRENGTH

Pain Reliever

Acetaminophen 500 mg / Pain Reliever / Fever Reducer

SOFTGELS*

(*Liquid-Filled Capsules)

Compare to Tylenol® Extra Strength active ingredient≠≠

≠≠This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Extra Strength.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY: WALGREENS CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Product Label

WALGREENS Extra Strength Pain Reliever

INGREDIENTS AND APPEARANCE

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0711
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
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE (UNII: FZ989GH94E)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	YELLOW	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	710
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0711-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	04/30/2016

Labeler - Walgreens (008965063)