PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet, coated 
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 Inc. Pain Relief Drug Facts

Active ingredient (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
toothache
muscular aches
premenstrual and menstrual cramps
minor pain of arthritis
temporarily reduces fever

Warnings

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

more than 8 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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 for more than 10 days
fever gets worse or lasts for 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.

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 Liver warning)

adults and children 12 years and over

take 2 caplets every 6 hours as needed
swallow whole – do not crush, chew or dissolve
do not take more than 8 caplets in 24 hours

children under 12 years

do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Inactive ingredients

flavors, hypromellose, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate*, starch, stearic acid, sucralose, titanium dioxide *may contain this ingredient

Questions or comments?

1-888-SAFEWAY

Principal Display Panel

Compare to Extra Strength Tylenol® Cool Caplets active ingredient

Extra Strength

Aspirin-Free

Pain Relief

Acetaminophen Caplets, 500 mg

Pain Reliever/Fever Reducer

Instant Cooling Sensation

Cool Ice® Caplets

See New Warnings Information

Actual Size

Pain Relief Carton Image #1

Pain Relief Carton Image #1

Pain Relief Carton Image #2

Pain Relief Carton Image #1

Pain Relief Carton Image #2

PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (tablet) Size18mm
FlavorVANILLA (Menthol) Imprint Code L010
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-010-711 in 1 CARTON01/25/200605/11/2013
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:21130-010-781 in 1 CARTON01/25/200605/11/2013
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/25/200605/11/2013
Labeler - Safeway (009137209)

Revised: 11/2017
 
Safeway