PAIN RELIEF- acetaminophen capsule, coated 
HyVee Inc

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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Hy-Vee, 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
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 have ever had an allergic reaction to this product or any of its ingredients

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 and children 12 years and over

take 2 caplets every 6 hours while symptoms last
do not take more than 6 caplets 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 at 20-25°C (68-77°F)

Inactive ingredients

croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, mica-based pearlescent pigment, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

COMPARE TO the Active Ingredient of Extra Strength Tylenol®

Pain Relief

Acetaminophen

Pain Reliever/Fever Reducer

Extra Strength – Rapid Release

ACTUAL SIZE

For Adults

Fast Relief

24 CAPLETS

500 mg EACH

HyVee Health Pain Relief image 1
HyVee Health Pain Relief image 2
PAIN RELIEF 
acetaminophen capsule, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-601
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code 3S0
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42507-601-621 in 1 CARTON11/01/201504/16/2019
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:42507-601-781 in 1 CARTON11/01/201504/15/2019
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 finalpart34311/01/201504/16/2019
Labeler - HyVee Inc (006925671)

Revised: 11/2019
 
HyVee Inc