PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet, film coated 
Rite Aid

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Pain Reliever

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take:

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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 of breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

caster oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Principal Display Panel

RITE
AID®
PHARMACY

*Compare to the active ingredient in Extra Strength Tylenol®

EXTRA STRENGTH
pain relief
acetaminophen

acetaminophen 500 mg
pain reliever • fever reducer

contains no aspirin

ACTUAL SIZE

24 CAPLETS

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® Caplets.
50844    REV0715C17508

DISTRIBUTED BY: RITE AID
30 HUNTER LANE, CAMP HILL, PA 17011

SATISFACTION GUARANTEE
RITE AID®

IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.

Rite Aid 44-175

Rite Aid 44-175



PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0812
Route of Administration ORAL DEA Schedule     
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)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CASTOR OIL (UNII: D5340Y2I9G)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 18mm
Flavor Imprint Code 44;175
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11822-0812-1 1 in 1 CARTON
1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2 NDC:11822-0812-2 1 in 1 CARTON
2 12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3 NDC:11822-0812-8 1 in 1 CARTON
3 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4 NDC:11822-0812-5 1 in 1 CARTON
4 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5 NDC:11822-0812-4 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 04/02/1993
Labeler - Rite Aid (014578892)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(11822-0812)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(11822-0812)

Revised: 11/2015
Document Id: 95d61a0f-6020-4cf9-9831-2b2779336b73
Set id: d846065a-5c39-4f4b-894c-4280acaaf4fa
Version: 9
Effective Time: 20151123
 
Rite Aid