EXTRA STRENGTH ASPIRIN FREE PAIN RELIEF- acetaminophen capsule 
Safeway

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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Safeway 44-445

Active ingredients (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer 

Uses

Warnings

Liver warnings: This product contains acetaminophen.  Severe liver damage may occur if you take:

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. 

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 befure use. 

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center 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

Other information

Inactive ingredients

corn starch, flavor, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide

*may contain this ingredient 

Questions or comments?

1-800-426-9391

Principal display panel

NDC 21130-445-15
Compare to Tylenol® Extra Strength Cool Caplets active ingredient†

Extra Strength
Aspirin Free Pain Relief
Acetaminophen
, 500 mg
• Cool Caplets
• Pain Reliever
• Fever Reducer

50 CAPLETS, 500 mg EACH

SAFEWAY

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Tylenol® Extra Strength Cool Caplets.

50844        REV0112A44515

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

Safeway 44-445

Safeway 44-445

EXTRA STRENGTH ASPIRIN FREE PAIN RELIEF 
acetaminophen capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-445
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
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code 44;445
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21130-445-15 1 in 1 CARTON
1 50 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 02/10/2005
Labeler - Safeway (009137209)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(21130-445)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(21130-445)

Revised: 10/2012
Document Id: d4224e04-32d4-4aca-a151-7040501d470f
Set id: fde76ae0-0362-40e4-ac83-d6c6b9264861
Version: 1
Effective Time: 20121005
 
Safeway