NON ASPIRIN PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl 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:
Freds Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever Nighttime sleep-aid temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Authorization status:
OTC monograph not final
Authorization number:
55315-360-10, 55315-360-50

NON ASPIRIN PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, coated

Freds 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.

----------

DRUG FACTS

Active ingredients (in each geltab)

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:

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

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

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.

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 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 geltabs at bedtime. Do not take more than 2 geltabs of

this product in 24 hours.

children under 12 years: do not use

Other information

store at room temperature 15 - 30 C (59 - 86 F)

avoid high humidity and excessive heat

Inactive ingredients

corn starch*, croscarmellose sodium*, D&C red #27 aluminum lake, edible black ink, FD&C blue #1

aluminum lake, gelatin, glycerin, hypromellose*, maltodextrin*, microcrystalline cellulose*,

polyethylene glycol*, povidone*, purified water, silicon dioxide*, stearic acid, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call toll free 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Compare to the active ingredients in extra strength TYLENOL® PM **

NON-ASPIRIN PM

extra strength

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

pain reliever/ nighttime sleep-aid

** This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the

registered trademark Extra Strength Tylenol® PM

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Product Label

Non-Aspirin PM Geltabs

NON ASPIRIN PM EXTRA STRENGTH

acetaminophen, diphenhydramine hcl tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55315-36 0

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

STARCH, CO RN (UNII: O8 232NY3SJ)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

D&C RED NO . 2 7 (UNII: 2LRS18 5U6 K)

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

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

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

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

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

WATER (UNII: 0 59 QF0 KO0 R)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

Product Characteristics

Color

BLUE, WHITE

S core

no sco re

S hap e

ROUND

S iz e

13mm

Flavor

Imprint Code

BPI50

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55315-36 0 -50

1 in 1 CARTON

11/30 /20 12

12/31/20 19

1

50 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:55315-36 0 -10

1 in 1 CARTON

11/30 /20 12

12/31/20 19

2

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Freds Inc

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part343

11/30 /20 12

12/31/20 19

Labeler -

Freds Inc (005866116)

Registrant -

P & L Development, LLC (800014821)

Revised: 4/2019

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