OTC Medication Information: Pain Reliever PM Extra Strength

PAIN RELIEVER PM EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride tablet, coated
BJWC (Berkley & Jensen / BJ’s)

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 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 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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 (see overdose warning)
  • 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 15°-30°C (59°-86°F)
  • avoid high humidity and excessive heat

Inactive ingredients

carnauba wax*, croscarmellose sodium*, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate*, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, polyvinyl alcohol*, povidone K30, pregelatinized starch, purified water*, silicon dioxide*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call toll free 1-800-934-1204 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Extra Strength Tylenol® PM

EXTRA STRENGTH

PAIN RELIEVER PM

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

PAIN RELIEVER/NIGHTTIME SLEEP-AID

NON HABIT-FORMING

FOR AGES 12+

CAPLETS

This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol® PM.

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

Distributed by: BJ’s Wholesale Club

25 Research Drive

Westborough, MA 01581

Questions? 1-800-934-1204

Package Label

Acetaminophen 500 mg, Diphenhydramine HCI 25 mg
(click image for full-size original)

BJ Extra Strength Pain Reliever PM

PAIN RELIEVER PM EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-447
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
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
FD&C BLUE NO. 2
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE K30
STEARIC ACID
STARCH, CORN
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A CORN
ALUMINUM OXIDE
CARNAUBA WAX
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
WATER
TALC
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code S525;P525;G651
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68391-447-05 500 TABLET, 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 12/31/2014 12/29/2023
Labeler — BJWC (Berkley & Jensen / BJ’s) (159082692)

Revised: 10/2021 BJWC (Berkley & Jensen / BJ’s)

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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