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Pain Relief Extra Strength by HEB

Medically reviewed on September 20, 2017

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: HEB
NDC Code: 37808-792

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.

1092 - HEB - 2017-0919

Drug Facts

Active ingredient (in each tablet)

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 are allergic to acetaminophen or any of the inactive ingredients in this product

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 tablets every 6 hours while symptoms last
  • swallow whole – do not crush, chew, or dissolve
  • do not take more than 6 tablets 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 between 20-25°C (68-77°F)
  • retain carton for complete product information

Inactive ingredients

acesulfame potassium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

Compare to Tylenol(R) Extra Strength active ingredient

HEB

NDC 37808-792-03

Extra Strength

Pain Relief

Acetaminophen, 500 mg

Pain Reliever/Fever Reducer

For Adults

Easy to Swallow Tabs; Sweet Coated

50 TABLETS

PAIN RELIEF   EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-792
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
FD&C RED NO. 40 
ALUMINUM OXIDE 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
POVIDONES 
STARCH, PREGELATINIZED CORN 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorredScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeA92
Contains    
Packaging
#Item CodePackage Description
1NDC:37808-792-031 BOTTLE, PLASTIC in 1 CARTON
150 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:37808-792-011 BOTTLE, PLASTIC in 1 CARTON
2100 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/01/2013
Labeler - HEB (007924756)

 
HEB

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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