rx act pain relief regular strength

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: H E B
NDC Code: 37808-403

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.

HEB Pain Relief Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

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

  • adult takes more than 12 tablets in 24 hours, which is the maximum daily amount for this product
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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 the user
  • has liver disease
  • is a child with pain of arthritis

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

Stop use and ask a doctor if
  • pain gets worse or lasts for more than 10 days (for adults) or 5 days (for children)
  • 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 tablets every 4 to 6 hours while symptoms last
  • do not take more than 12 tablets in 24 hours

children

6-11 years
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours

children under

6 years
  • do not use this adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Inactive ingredients

croscarmellose sodium*, povidone, pregelatinized starch, stearic acid *may contain this ingredient

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Regular Strength Tylenol® Tablets active ingredient

PAIN RELIEF

Regular Strength

Acetaminophen

ACTUAL SIZE

Pain Reliever - Fever Reducer

See New Warnings Information

GLUTEN FREE

325mg

Pain Relief Carton Image 1

Pain Relief Carton Image 2

RX ACT PAIN RELIEF  REGULAR STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-403
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
POVIDONE 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (beveled edge) Size10mm
FlavorImprint Code325MG;L403
Contains    
Packaging
#Item CodePackage Description
1NDC:37808-403-781 BOTTLE (BOTTLE) in 1 CARTON
1100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/15/1992
Labeler - H E B (007924756)

Revised: 04/2010
 
H E B

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)