ACETAMINOPHEN PM EXTRA STRENGTH diphenhydramine hcl capsule coated

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

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Western Family Foods Inc
INN (International Name):
ACETAMINOPHEN
Composition:
ACETAMINOPHEN 500 mg
Prescription type:
OTC DRUG
Authorization status:
OTC monograph final

ACETAMINOPHEN PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl capsule,

coated

Western Family Foods Inc

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.

----------

Western Family Acetaminophen PM Drug Facts

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpos e

Pain reliever

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

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

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

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

liver disease

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland

glaucoma

taking the blood thinning drug warfarin

taking sedatives or tranquilizers

When using this product

Stop use and ask a doctor if

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.

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

children under 12 years

do not use this adult product in children under 12 years of age; this will provide

more than the recommended dose (overdose) and may cause liver damage

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, edible ink, FD&C

blue #1, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, FD&C yellow

#6 aluminum lake, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose,

povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin

Package/Label Principal Display Panel

Pain Reliever & Nighttime Sleep-Aid

Extra Strength

Acetaminophen PM

drowsiness will occur

avoid alcoholic drinks

do not drive a motor vehicle or operate machinery

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

do not take more than directed (see Liver warning)

take 2 gelcaps at bedtime

do not take more than 2 gelcaps of this product in 24 hours

Contains Acetaminophen & Diphenhydramine HCl

Rapid Release

Non-Habit Forming

Actual Size

COMPARE TO TYLENOL® PM active ingredients

Aspirin Free

ACETAMINOPHEN PM EXTRA STRENGTH

acetaminophen, diphenhydramine hcl capsule, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55312-8 29

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)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

D&C RED NO . 2 8 (UNII: 76 7IP0 Y5NH)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

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

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GELATIN (UNII: 2G8 6 QN327L)

HYDRO XYPRO PYL CELLULO SE ( TYPE H) (UNII: RFW2ET6 71P)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

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

PO VIDO NES (UNII: FZ9 8 9 GH9 4E)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

Product Characteristics

Western Family Foods Inc

Color

BLUE (Dark Blue Opaque) , GRAY, BLUE (Light Blue Opaque)

S core

no sco re

S hap e

CAPSULE

S iz e

22mm

Flavor

Imprint Code

L8 29

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55312-8 29 -49

1 in 1 CARTON

1

40 in 1 BOTTLE

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 rt338

0 8 /26 /20 10

Labeler -

Western Family Foods Inc (192166072)

Revised: 2/2013

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