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Heb

acetaminophen · Heb is an over-the-counter drug containing acetaminophen, made by HEB.

Type
Over the counter
Drug class
Not classified
Route
Oral
Manufacturers
1

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

Drug facts

Generic name
acetaminophen
Active ingredients
Acetaminophen
Dosage forms
Tablet, extended release
Label holder
HEB
FDA application
ANDA211544
Label updated
04/12/2023

Active ingredients

(in each caplet) Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

Directions

Do not take more than directed (see overdose warning) adults take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve 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 under 18 years of age ask a doctor

Warnings

Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 6 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 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.

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

Liver disease

Ask a doctor or pharmacist before use

Taking the blood thinning drug warfarin

Stop use and ask a doctor

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.

Pregnancy or breastfeeding

Ask a health professional before use.

Keep out of reach of children

Keep out of reach of children.

Other information

Store between 20-25°C (68-77°F) retain carton for complete product information and warnings

Inactive ingredients

Hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions?

1-844-705-4384

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Tablet, extended release650 mgoral1

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 445,036 reports that list acetaminophen, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Drug ineffective37,633
  • Fatigue36,342
  • Off label use34,857
  • Nausea31,499
  • Headache30,238
  • Pain29,611
  • Diarrhea25,002
  • Dyspnea24,049
  • Arthralgia23,147
  • Vomiting22,036

To report a side effect, use FDA MedWatch.

Manufacturers and labels

1 FDA label

  • HEBShown hereANDA211544 · Label 04/12/2023 · NDC 37808-120Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Heb: common questions

What is Heb used for?
temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever
Is Heb a prescription drug?
No. Heb is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Heb?
Yes. Other FDA-listed products with the same active ingredients include Pain Reliever, Pain Relief, Childrens Pain and Fever, Pain Relief Extra Strength.
Who makes Heb?
HEB lists Heb with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 04/12/2023 · Label text is shown as published by the manufacturer. Not medical advice