OTC Medication Information: Acetaminophen Pm

ACETAMINOPHEN PM- acetaminophen and diphenhydramine hydrochloride tablet, film coated
Kroger Company

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 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

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

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-632-6900

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EXTRA STRENGTH

Acetaminophen PM

Acetaminophen/Diphenhydramine HCl

Pain Reliever

Nighttime Sleep Aid

Non-Habit forming

actual size

100 CAPLETS

Acetaminophen PM Image 1
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Acetaminophen PM Image 2
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ACETAMINOPHEN PM
acetaminophen, diphenhydramine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-800
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
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE, UNSPECIFIED
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code L751
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:30142-800-71 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (30142-800-71)
2 NDC:30142-800-82 2 BOTTLE in 1 CARTON contains a BOTTLE
2 100 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (30142-800-82)
3 NDC:30142-800-78 1 BOTTLE in 1 CARTON contains a BOTTLE
3 100 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (30142-800-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 08/05/2014
Labeler — Kroger Company (006999528)

Revised: 11/2019 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.

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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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