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Diphenhydramine Hydrochloride by Proficient Rx LP

Medically reviewed on February 1, 2018

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Proficient Rx LP
NDC Code: 63187-446

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.

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, USP 25mg

Drug Facts

.

Active Ingredient

(in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

runny nose
itchy nose or throat
sneezing
itchy, watery eyes

WARNINGS

Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
 
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
 
When using this product
you may get very drowsy
avoid alcoholic drinks
alcohol, sedatives & tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children
 
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.

Directions
adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours
children under 12 years: ask a doctor

Other Information
store at 15-30 °C (59-86 °F)
protect from moisture
For 1000 Count: This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP

Inactive Ingredients

benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel sulfate

Questions or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

Distributed by: Qualitest Pharmaceuticals, Inc.

Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP 25 MG

ANTIHISTAMINE

NDC: 63187-446-30

NDC: 63187-446-60

NDC: 63187-446-90

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-446(NDC:0603-3339)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
BUTYLPARABEN 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLPARABEN 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeAP;020
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-446-3030 CAPSULE in 1 BOTTLE
2NDC:63187-446-6060 CAPSULE in 1 BOTTLE
3NDC:63187-446-9090 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/24/2007
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079196022REPACK(63187-446), RELABEL(63187-446)

 
Proficient Rx LP

← See all Diphenhydramine Hydrochloride brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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