Dye Free Allergy Relief

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Polyethylene Glycol 400 Propylene Glycol Povidone Sorbitol Sorbitan Water Light Mineral Oil Gelatin Glycerin Isopropyl Alcohol

Identifiers & Packaging

Pill Appearance

Imprint: SD12;SDA Shape: capsule Color: white Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-04-07

Medication Information

Purpose

Antihistamine

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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).

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
trouble urinating due to an enlarged prostate gland
glaucoma

Section 50570-1

Do not use

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Section 53414-9

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

uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
itchy, watery eyes
sneezing
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 times in 24 hours

adults & children 12 yrs & over	1 to 2 Softgels
children 6 to under 12 yrs	1 Softgel
children under 6 yrs	do not use

Other Information

store between 20-25° C (68-77° F)
Avoid high humidity and excessive heat
protect from moisture and light

Inactive Ingredients

gelatin, glycerin, isopropyl alcohol*, light mineral oil*, polyethylene glycol-400, propylene glycol, povidone, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions Or Comments?

1-800-373-6981 (toll-free)

Principal Display Panel

TopCare health

Dye-Free

Allergy Relief

Diphenhydramine HCl 25 mg

Relieves

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

Diphenhydramine HCl 25 mg

No artificial flavors

No synthetic colors

Gluten free*

Non-GMO

Carton

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25 mg

Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

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
trouble urinating due to an enlarged prostate gland
glaucoma

Section 50570-1 (50570-1)

Do not use

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Section 53414-9 (53414-9)

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

Purpose

Antihistamine

uses (Uses)

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
itchy, watery eyes
sneezing
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 times in 24 hours

adults & children 12 yrs & over	1 to 2 Softgels
children 6 to under 12 yrs	1 Softgel
children under 6 yrs	do not use

Other Information (Other information)

store between 20-25° C (68-77° F)
Avoid high humidity and excessive heat
protect from moisture and light

Inactive Ingredients (Inactive ingredients)

gelatin, glycerin, isopropyl alcohol*, light mineral oil*, polyethylene glycol-400, propylene glycol, povidone, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions Or Comments? (Questions or comments?)

1-800-373-6981 (toll-free)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

TopCare health

Dye-Free

Allergy Relief

Diphenhydramine HCl 25 mg

Relieves

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

Diphenhydramine HCl 25 mg

No artificial flavors

No synthetic colors

Gluten free*

Non-GMO

Carton

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"42229-5": "Drug Facts", "50565-1": "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).", "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 trouble urinating due to an enlarged prostate gland glaucoma", "50570-1": "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antihistamine", "Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing 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 times in 24 hours adults & children 12 yrs & over 1 to 2 Softgels children 6 to under 12 yrs 1 Softgel children under 6 yrs do not use", "Other information": "store between 20-25° C (68-77° F) Avoid high humidity and excessive heat protect from moisture and light", "Inactive ingredients": "gelatin, glycerin, isopropyl alcohol*, light mineral oil*, polyethylene glycol-400, propylene glycol, povidone, purified water, sorbitol sorbitan solution *may contain this ingredient", "Questions or comments?": "1-800-373-6981 (toll-free)", "PRINCIPAL DISPLAY PANEL": "TopCare health Dye-Free Allergy Relief Diphenhydramine HCl 25 mg Relieves Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat Diphenhydramine HCl 25 mg No artificial flavors No synthetic colors Gluten free* Non-GMO Carton", "Active ingredient (in each softgel)": "Diphenhydramine HCl 25 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information