OTC Medication Information: Acetaminophen

ACETAMINOPHEN- acetaminophen tablet, film coated
ARMY AND AIR FORCE EXCHANGE SERVICE

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.

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • the common cold
    • toothache
    • backache
    • muscular aches
    • minor pain of arthritis
    • 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

  • 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 of breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets 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)
  • use by expiration date on package

Inactive ingredients

castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Questions or comments?

1-800-426-9391

Principal Display Panel

exchange
select™

Compare To The Active
Ingredient of Extra Strength
Tylenol® Caplets
Contains no aspirin

ACETAMINOPHEN

Pain Reliever EXTRA
Fever Reducer STRENGTH

200 CAPLETS 500mg each Actual Size ✓quality value

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 Extra Strength Tylenol® Caplets.

“SATISFACTION GUARANTEED OR YOUR MONEY BACK”
Manufactured For Your Military Exchanges
Distributed by: LNK International, Inc.,
Hauppauge, NY 11788 1-800-426-9391

50844 REV0617C17506

Exchange Select 44-175
(click image for full-size original)

Exchange Select 44-175

ACETAMINOPHEN
acetaminophen tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-175
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
HYPROMELLOSE, UNSPECIFIED
STEARIC ACID
CASTOR OIL
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
STARCH, CORN
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 44;175
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55301-175-15 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (55301-175-15)
2 NDC:55301-175-03 1 BOTTLE in 1 CARTON contains a BOTTLE
2 10 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (55301-175-03)
3 NDC:55301-175-12 1 BOTTLE in 1 CARTON contains a BOTTLE
3 100 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (55301-175-12)
4 NDC:55301-175-06 2 BOTTLE in 1 CARTON contains a BOTTLE
4 100 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (55301-175-06)
5 NDC:55301-175-60 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 04/02/1993
Labeler — ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 PACK (55301-175)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 MANUFACTURE (55301-175), PACK (55301-175)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 PACK (55301-175)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 PACK (55301-175)

Revised: 02/2021 ARMY AND AIR FORCE EXCHANGE SERVICE

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.

Medication Sections

Medication Information by RSS

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.

Terms of Use | Copyright © 2021. All Rights Reserved.