ALLERGY- diphenhydramine hcl tablet

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

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
Mechanical Servants, LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies - sneezing - nasal congestion - runny nose - itchy, watery eyes Temporarily relieves these symptoms due to common cold - runny nose - sneezing
Authorization status:
OTC monograph final
Authorization number:
29485-7007-6

ALLERGY- diphenhydramine hcl tablet

Mechanical Servants, LLC

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.

----------

Allergy

Active ingredient

(in each caplet)

Diphenhydramine HCl (25 mg)

Antihistamine

Us es

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

sneezing

nasal congestion

runny nose

itchy, watery eyes

Temporarily relieves these symptoms due to common cold

runny nose

sneezing

Warnings

Do not use

to make a child sleepy

with any other product containing Diphenhydramine, even one used on the skin

Ask a doctor before use if you have

trouble urinating due to an enlarged prostate gland

a breathing problem such as emphysema or chronic bronchitis

glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

avoid alcoholic drinks

marked drowsiness may occur

excitability may occur, especially in children

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding

ask a health professional before use

Keep out of the reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take every 4 to 6 hours, or as directed by a doctor

do not take more than 6 doses in 24 hours

adults and children 12 years and over 1 to 2 tablets

children 6 to under 12 years 1 tablet

children under 6 years ask a doctor

Inactive ingredients

colloidal silicon dioxide, corn starch, D & C red # 27 Aluminum lake, dicalcium phosphate, magnesium

stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium

dioxide

Questions or comments?

Call 1-844-428-2538

ALLERGY

diphenhydramine hcl tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:29 48 5-70 0 7

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

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

Mechanical Servants, LLC

ANHYDRO US DIBASIC CALCIUM PHO SPHATE (UNII: L11K75P9 2J)

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

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

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

STARCH, CO RN (UNII: O8 232NY3SJ)

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

TALC (UNII: 7SEV7J4R1U)

Product Characteristics

Color

pink (Pink)

S core

no sco re

S hap e

OVAL

S iz e

11mm

Flavor

Imprint Code

PH25

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:29 48 5-70 0 7-6

6 in 1 PACKAGE

0 3/13/20 19

1

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

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 3/13/20 19

Labeler -

Mechanical Servants, LLC (005530951)

Revised: 3/2019

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