RX ACT PAIN RELIEF EXTRA STRENGTH- acetaminophen capsule, coated 
H E B

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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HEB 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 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 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.

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 use more than directed (see Liver warning)

adults and children 12 years and over

take 2 caplets every 6 hours as needed
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

Other information

store at 20º-25ºC (68º-77ºF)

Inactive ingredients

hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Extra Strength Tylenol® Caplets active ingredient

PAIN RELIEF

Extra Strength

Acetaminophen

ACTUAL SIZE

Pain Reliever - Fever Reducer

See New Warnings Information

500 mg

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RX ACT PAIN RELIEF  EXTRA STRENGTH
acetaminophen capsule, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-917
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)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code L917
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-917-621 in 1 CARTON03/21/201103/23/2014
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:37808-917-711 in 1 CARTON03/21/201103/23/2014
250 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/21/201103/23/2014
Labeler - H E B (007924756)
Registrant - L. Perrigo Company (006013346)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918457644MANUFACTURE(37808-917)
Establishment
NameAddressID/FEIBusiness Operations
L. Perrigo Company006013346LABEL(37808-917)
Establishment
NameAddressID/FEIBusiness Operations
Sixarp LLC, Praxis016329513REPACK(37808-917)

Revised: 11/2017
 
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