Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Ferrosoferric Oxide D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Lactose Monohydrate Magnesium Stearate Silicon Dioxide Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance

Imprint: PH013 Shape: capsule Color: pink Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2010-01-27

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCL 50 mg

Uses:

Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies

sneezing
nasal congestion
runny nose
itchy, watery eyes

Section 51945-4

Diphenhydramine

HCl Capsules, USP

50 mg

TAMPER-EVIDENT: DO NOT USE IF SAFETY

SEAL IS BROKEN OR MISSING FROM BOTTLE

ANTIHISTAMINE

Warnings:

Do Not Use

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

Directions:

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

Adults and children 12 years & 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

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

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away 1(800) 222-1222.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Capsule)

Diphenhydramine HCL 50 mg

Questions? Adverse Drug Event Call:

1-800-687-0176

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

Structured Label Content

Uses:

Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies

sneezing
nasal congestion
runny nose
itchy, watery eyes

Section 51945-4 (51945-4)

Diphenhydramine

HCl Capsules, USP

50 mg

TAMPER-EVIDENT: DO NOT USE IF SAFETY

SEAL IS BROKEN OR MISSING FROM BOTTLE

ANTIHISTAMINE

Purpose

Antihistamine

Warnings:

Do Not Use (Do not use)

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

Directions:

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

Adults and children 12 years & 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: (Other information:)

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

Inactive Ingredients: (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

When Using This Product (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

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center right away 1(800) 222-1222.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine HCL 50 mg

Questions? Adverse Drug Event Call: (Questions? Adverse drug event call:)

1-800-687-0176

Ask A Doctor Or Pharmacist Before Use (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

Advanced Ingredient Data

[{"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 28", "unii": "767IP0Y5NH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses:": "Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies sneezing nasal congestion runny nose itchy, watery eyes", "51945-4": "Diphenhydramine HCl Capsules, USP 50 mg TAMPER-EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE ANTIHISTAMINE", "Purpose": "Antihistamine", "Do not use": "With any other product containing Diphenhydramine HCL, including one applied topically.", "Directions:": "Take every 4-6 hours Do not take more than 6 doses in 24 hours. Adults and children 12 years & 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", "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", "Keep out of reach of children": "In case of overdose, get medical help or contact a Poison Control Center right away 1(800) 222-1222.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Active ingredient (in each capsule)": "Diphenhydramine HCL 50 mg", "Questions? Adverse drug event call:": "1-800-687-0176", "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"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information