ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG tablet

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

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Strive Pharmaceuticals Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness Pain reliever Nighttime sleep-aid
Authorization status:
OTC monograph not final
Authorization number:
70692-119-05, 70692-119-41

ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG- acetaminophen 500mg

diphenhydramine hcl 25mg tablet

Strive Pharmaceuticals 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.

----------

Pain Relief PM - Extra Strength

Body Pain - Dolor Corporal

(Acetaminophen 500mg; Diphenhydramine Hydrochloride 25mg)

Acetaminophen 500mg; Diphenhydramine 25mg

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methyl cellulose,

magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, talc,

titanium dioxide

take with a full glass of water

do not take more than directed

do not take more than 2 caplets in 24 hours

adults and children 12 years of age and over

2 caplets at bedtime

do not take more than 2 caplets in 24 hours

children under 12 years of age

do not use

*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

more than 4000mg 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 non prescription). 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 youhave 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 prostrate gland

glaucoma

Ask a doctor or a pharmacist before use if you are

taking the blood thinning drug warfarin

taking sedatives or tranquilizers

When using this product

drowsiness will occur

avoi 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

new symptoms occur

redness or swelling is present

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 accidental overdose, get medical help or contact a Poison Control

Center right away. Prompt medical attention is critical for adults as well as for children even if you do

not notice any signs or symptoms.

Keep out of reach of children

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control

Center right away. Prompt medical attention is critical for adults as well as for children even if you do

not notice any signs or symptoms.

Pain reliever

Nighttime sleep-aid

store at room temperature between 20

C - 25

C (68

F - 77

ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG

acetaminophen 500mg diphenhydramine hcl 25mg tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 6 9 2-119

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

25 mg

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

ACETAMINOPHEN

50 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

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

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

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

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

STARCH, CO RN (UNII: O8 232NY3SJ)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

blue (LIGHT BLUE)

S core

no sco re

S hap e

CAPSULE

S iz e

18 mm

Flavor

Imprint Code

AD0 1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 6 9 2-119 -41

4 in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

12/20 /20 18

2

NDC:70 6 9 2-119 -0 5

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

0 9 /23/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

12/20 /20 18

Strive Pharmaceuticals Inc

Labeler -

Strive Pharmaceuticals Inc (080028013)

Revised: 11/2019

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