OTC Medication Information: Pain Relief Extra Strength

PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet, coated
H E B

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • the common cold
    • 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:

  • blisters
  • rash
  • skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • 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. Prompt 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
  • adults and children 12 years and over
    • take 2 gelcaps every 6 hours while symptoms last
    • do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • avoid high humidity
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Compare to Tylenol® Extra Strength
Rapid Release Gels active ingredient*

NDC 37808-195-08

H-E-B®

Extra Strength
Pain Relief
Acetaminophen
500 mg
Pain Reliever/Fever Reducer

24 GELCAPS

actual
size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed
by Johnson & Johnson Corporation, owner of the
registered trademark Tylenol® Extra Strength
Rapid Release Gels.
50844 REV0322A51908

MADE WITH PRIDE AND CARE FOR
H-E-B®, SAN ANTONIO, TX 78204

H•E•B ®

100%
GUARANTEE
promise

If you aren’t completely
pleased with this product,
we’ll be happy to replace
it or refund your money.You have our word on it.

HEB 44-519
(click image for full-size original)

HEB 44-519

PAIN RELIEF EXTRA STRENGTH acetaminophen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-195
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
STARCH, CORN
PROPYLENE GLYCOL
SHELLAC
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color red, blue Score no score
Shape OVAL Size 19mm
Flavor Imprint Code L;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37808-195-08 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 24 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (37808-195-08)
2 NDC:37808-195-12 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 100 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (37808-195-12)
3 NDC:37808-195-20 225 TABLET, COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 05/10/2004
Labeler — H E B (007924756)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 manufacture (37808-195), pack (37808-195)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (37808-195)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (37808-195)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 manufacture (37808-195)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (37808-195)

Revised: 09/2023 H E B

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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