OTC Medication Information: Pain Relief PM Extra Strength

PAIN RELIEF PM EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride tablet, coated
HEB

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.

Drug Facts

Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg Pain reliever
Diphenhydramine HCl 25 mg 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • drowsiness will occur
  • avoid alcoholic drinks
  • 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 serious underlying medical illness.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

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

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 between 20-25°C (68-77°F) in a dry place
  • retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

Compare to Tylenol® PM Extra Strength Caplets active ingredients

HEB

NDC 37808-795-03

Extra Strength

Pain Relief PM

Acetaminophen, 500 mg

Diphenhydramine HCl, 25 mg

Pain Reliever/Nighttime Sleep-Aid

For Adults; Non-Habit Forming

100 CAPLETS

image description
(click image for full-size original)
PAIN RELIEF PM EXTRA STRENGTH
acetaminophen and diphenhydramine hydrochloride tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-795
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
SILICON DIOXIDE
COPOVIDONE K25-31
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
STARCH, PREGELATINIZED CORN
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape OVAL Size 17mm
Flavor Imprint Code AAA;1031
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37808-795-03 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 100 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (37808-795-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 02/01/2013
Labeler — HEB (007924756)

Revised: 10/2019 HEB

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 © 2019. All Rights Reserved.