879a7804-f3d4-4a3d-bc92-b473499d6c95

SPL v6

SPL

SPL Set ID 879a7804-f3d4-4a3d-bc92-b473499d6c95

Route

oral

Published

Effective Date 2025-08-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (25 mg)

Inactive Ingredients

d&c red no. 28 fd&c blue no. 1 fd&c red no. 40 magnesium stearate gelatin lactose monohydrate sodium lauryl sulfate starch, corn

Identifiers & Packaging

Pill Appearance

Imprint: CPC;835 Shape: capsule Color: pink Size: 14 mm Score: 1

Marketing Status

otc monograph drug completed Since 2022-04-14 Until 2028-02-29

Description

Active ingredient (in each capsule) Diphenhydramine HCl 25 mg

Medication Information

Uses

 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, watery eyes  itching of the nose or throat

 temporarily relieves these symptoms due to the common cold:  runny nose  sneezing

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 of age and over	1 to 2 capsules
children 6 to under 12 years of age	1 capsule
children under 6 years of age	do not use this product in children under 6 years of age

Other Information

 store in a dry place at 15° – 30°C (59° – 86°F)

Description

Active ingredient (in each capsule) Diphenhydramine HCl 25 mg

Section 34088-5

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

Section 42229-5

TAMPER EVIDENT: DO NOT USE IF SAFTY SEAL IS BROKEN OF MISSING FROM BOTTLE

DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING.

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product

 marked drowsiness may occur

 avoid alcoholic drinks

 alcohol, sedatives and tranquilizers may increase drowsiness

 be careful when driving a motor vehicle or operating machinery

 excitability may occur, especially in children

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

 a breathing problem such as emphysema or chronic bronchitis

 glaucoma

 trouble urinating due to an enlarged prostate gland

Section 50570-1

 to make a child sleepy

 with any other product containing diphenhydramine, even one used on skin

Section 51727-6

corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Section 51945-4

Diphenhydramin HCl 25 mg

Antihistamine

EACH CAPSULE INDIVIDUALLY

BANDED FOR YOUR PROTECTION

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Antihistamine

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Questions Or Comments?

1-800-616-2471

Structured Label Content

Uses

 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, watery eyes  itching of the nose or throat

 temporarily relieves these symptoms due to the common cold:  runny nose  sneezing

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 of age and over	1 to 2 capsules
children 6 to under 12 years of age	1 capsule
children under 6 years of age	do not use this product in children under 6 years of age

Other Information (Other information)

 store in a dry place at 15° – 30°C (59° – 86°F)

Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF SAFTY SEAL IS BROKEN OF MISSING FROM BOTTLE

DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product

 marked drowsiness may occur

 avoid alcoholic drinks

 alcohol, sedatives and tranquilizers may increase drowsiness

 be careful when driving a motor vehicle or operating machinery

 excitability may occur, especially in children

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

 a breathing problem such as emphysema or chronic bronchitis

 glaucoma

 trouble urinating due to an enlarged prostate gland

Section 50570-1 (50570-1)

 to make a child sleepy

 with any other product containing diphenhydramine, even one used on skin

Section 51727-6 (51727-6)

corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Section 51945-4 (51945-4)

Diphenhydramin HCl 25 mg

Antihistamine

EACH CAPSULE INDIVIDUALLY

BANDED FOR YOUR PROTECTION

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Antihistamine

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Questions Or Comments? (Questions or comments?)

1-800-616-2471

Advanced Ingredient Data

[{"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": "MAGNESIUM STEARATE", "unii": "70097M6I30", "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": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": " temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, watery eyes  itching of the nose or throat  temporarily relieves these symptoms due to the common cold:  runny nose  sneezing", "34088-5": "In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).", "42229-5": "TAMPER EVIDENT: DO NOT USE IF SAFTY SEAL IS BROKEN OF MISSING FROM BOTTLE DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING.", "50565-1": "Keep out of reach of children.", "50567-7": "When using this product  marked drowsiness may occur  avoid alcoholic drinks  alcohol, sedatives and tranquilizers may increase drowsiness  be careful when driving a motor vehicle or operating machinery  excitability may occur, especially in children", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "50569-3": "Ask a doctor before use if you have  a breathing problem such as emphysema or chronic bronchitis  glaucoma  trouble urinating due to an enlarged prostate gland", "50570-1": " to make a child sleepy  with any other product containing diphenhydramine, even one used on skin", "51727-6": "corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate", "51945-4": "Diphenhydramin HCl 25 mg Antihistamine EACH CAPSULE INDIVIDUALLY BANDED FOR YOUR PROTECTION", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "55105-1": "Purpose Antihistamine", "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 of age and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age", "Drug Facts": "Active ingredient (in each capsule) Diphenhydramine HCl 25 mg", "Other information": " store in a dry place at 15° – 30°C (59° – 86°F)", "Questions or comments?": "1-800-616-2471"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:35.272930 · Updated: 2026-03-14T23:14:00.268297