OTC Medication Information: Extra Strength Acetaminophen PM

EXTRA STRENGTH ACETAMINOPHEN PM- acetaminophen and diphenhydramine hydrochloride tablet
KROGER COMPANY

Drug Facts

Active ingredients (in each caplet) Purpose
Acetaminophen 500mg 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

  • 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.
  • with any other product containing diphenhydramine, even one used on skin
  • 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. 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 at room temperature between 20-25°C (68-77°F)

Inactive ingredients

croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, purified water, silicon dioxide, sodium starch glycolate, corn starch, talc, titanium dioxide

Questions or comments?

call 1-800-632-6900

PRINCIPAL DISPLAY PANEL — 100 Caplet Bottle Carton

COMPARE TO the active ingredients of
TYLENOL® PM EXTRA STRENGTH CAPLETS *See side panel

NDC 30142-755-01

Kroger®
for adults

Extra Strength

Acetaminophen PM
Acetaminophen,
Diphenhydramine HCl

Pain Reliever/Nighttime Sleep-Aid
Non-Habit Forming

OUR PHARMACIST RECOMMENDED

actual
size

100 CAPLETS

PRINCIPAL DISPLAY PANEL -- 100 Caplet Bottle Carton
(click image for full-size original)
EXTRA STRENGTH ACETAMINOPHEN PM
acetaminophen and diphenhydramine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-755
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
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
WATER
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 18mm
Flavor Imprint Code S149
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:30142-755-05 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 TABLET in 1 BOTTLE This package is contained within the CARTON (30142-755-05)
2 NDC:30142-755-01 1 BOTTLE in 1 CARTON contains a BOTTLE
2 100 TABLET in 1 BOTTLE This package is contained within the CARTON (30142-755-01)
3 NDC:30142-755-20 2 BOTTLE in 1 CARTON contains a BOTTLE
3 100 TABLET in 1 BOTTLE This package is contained within the CARTON (30142-755-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 05/01/2021
Labeler — KROGER COMPANY (006999528)

Revised: 01/2024 KROGER COMPANY

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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