PAIN RELIEF PM- acetaminophen and diphenhydramine hydrochloride tablet, coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
Meijer
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Authorization status:
OTC monograph final
Authorization number:
41250-195-02, 41250-195-03, 41250-195-09

PAIN RELIEF PM- acetaminophen and diphenhydramine hydrochloride tablet, coated

Meijer

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.

----------

MEI-1095-2019-0904

Drug Facts

Active ingredients

(in each caplet)

Purpose

Acetaminophen 500 mg

Pain reliever

Diphenhydramine HCl 25 mg

Nighttime

sleep aid

Us es

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

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

NDC 41250-195-02

Compare to Extra Strength Tylenol® PM active ingredients†

Meijer®

For Adults

pain relief PM

Acetaminophen, Diphenhydramine HCl

Extra Strength

Pain Reliever, Nighttime Sleep Aid

50 CAPLETS

actual size

PAIN RELIEF PM

acetaminophen and diphenhydramine hydrochloride tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -19 5

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

50 0 mg

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE -

UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CO PO VIDO NE K2 5-3 1 (UNII: D9 C330 MD8 B)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

LACTO SE (UNII: J2B2A4N9 8 G)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

STARCH, PREGELATINIZED CO RN (UNII: O8 232NY3SJ)

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

blue

S core

no sco re

S hap e

OVAL

S iz e

17mm

Flavor

Imprint Code

AAA;10 31

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:41250 -19 5-

1 in 1 CARTON

0 5/0 1/20 17

1

50 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

2

NDC:41250 -19 5-

1 in 1 CARTON

0 5/0 1/20 17

2

10 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

3

NDC:41250 -19 5-

2 in 1 CARTON

0 5/0 1/20 17

3

10 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Me ije r

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 5/0 1/20 17

Labeler -

Meijer (006959555)

Revised: 9/2019

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