Diphenhydramine HCL by REMEDYREPACK INC. Drug Facts

Drug Details [pdf]

DIPHENHYDRAMINE HCL- diphenhydramine hcl capsule
REMEDYREPACK 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 ingredient(in each capsule)

Diphenhydramine HCL 50 mg

Purpose

Antihistamine

Uses:

Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.
Sneezing.
Nasal congestion.
Runny nose.
Itchy, watery eyes.

Warnings:

Do not use

With any other product containing Diphenhydramine HCL, including one applied topically.

Ask a doctor or pharmacist before use

If you have

Trouble urinating due to enlarged prostate gland
A breathing problem such as emphysema or chronic bronchitis
Glaucoma
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 reach of children

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

Directions:

Take every 4-6 hours
Do not take more than 6 doses in 24 hours.

Adults and children 12 years or over

1 capsule

Children under 12 years

ask a doctor

**25 mg strength is not available in this package. Do not attempt to break capsules.

Other information:

Store at room temperature 15-30 degrees C (59-86 degrees F)
Protect from excessive moisture

Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate

Questions? Adverse drug event call:

1-800-687-0176

DRUG: Diphenhydramine HCL

GENERIC: Diphenhydramine HCL

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-0525-0

COLOR: pink

SHAPE: CAPSULE

SCORE: No score

SIZE: 14 mm

IMPRINT: PH013

PACKAGING: 10 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 1

INACTIVE INGREDIENT(S):

FERROSOFERRIC OXIDE
MAGNESIUM STEARATE
LACTOSE MONOHYDRATE
SILICON DIOXIDE
GELATIN
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
SODIUM LAURYL SULFATE

Remedy_Label

DIPHENHYDRAMINE HCL
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-0525(NDC: 66424-021)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	PH013
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70518-0525-0	10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/11/2017	04/06/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	05/11/2017	04/06/2020

Labeler - REMEDYREPACK INC. (829572556)

Revised: 4/2020

Document Id: a2ab51a4-6ab8-f508-e053-2995a90ab6ac

Set id: af4f1587-8bd1-45dd-9310-0a5836660a32

Version: 4

Effective Time: 20200406