Acetaminophen PM Extra Strength: Package Insert and Label Information

ACETAMINOPHEN PM EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride 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 ingredients (in each caplet)

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purpose

Pain reliever
Nighttime sleep-aid

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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 product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • 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 have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • liver disease
  • glaucoma

  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

  • taking sedatives or tranquilizers

When using this product

  • avoid alcoholic beverages
  • drowsiness will occur

  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • new symptoms occur

  • redness or swelling is present

  • pain gets worse or lasts more than 10 days

  • fever gets worse or lasts more than 3 days

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 accidental 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 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.

  • children under 12 years: do not use

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

exchange √select

Compare To The Active Ingredients of
Extra Strength Tylenol® PM*

Extra Strength
Acetaminophen PM

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain Reliever/Nighttime Sleep-Aid

Actual Size

50 Caplets

Contains no aspirin • Non-habit forming

quality value

*This product is not manufactured or distributed
by Johnson & Johnson Corporation, owner of the
registered trademark Extra Strength Tylenol® PM.

50844 REV0521P23515

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

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

Exchange Select 44-235
(click image for full-size original)

Exchange Select 44-235

ACETAMINOPHEN PM EXTRA STRENGTH acetaminophen, diphenhydramine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-235
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1 ALUMINUM LAKE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
STEARIC ACID
TALC
TITANIUM DIOXIDE
SILICON DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
Product Characteristics
Color blue Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 44;235
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55301-235-15 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (55301-235-15)
2 NDC:55301-235-06 200 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 05/15/1994
Labeler — ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (55301-235)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (55301-235), pack (55301-235)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (55301-235)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 pack (55301-235)

Revised: 09/2021 ARMY AND AIR FORCE EXCHANGE SERVICE

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.