topcare health allergy relief tablets

topcare health allergy relief tablets
SPL v7
SPL
SPL Set ID ad676e67-4cdd-41bb-8bd8-0c5868539fea
Route
oral
Published
Effective Date 2021-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
silicon dioxide croscarmellose sodium d&c red no. 27 anhydrous dibasic calcium phosphate lecithin, soybean magnesium stearate microcrystalline cellulose polyvinyl alcohol, unspecified polyethylene glycol, unspecified talc titanium dioxide water

Identifiers & Packaging

Pill Appearance
Imprint: S4 Shape: oval Color: pink Size: 12 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-08-10
Purpose

Antihistamine

Description

Drug Facts

Medication Information

Active Ingredient

Diphenhydramine HCl 25 mg

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
Purpose

Antihistamine

Directions
  • take every 4 to 6 hours or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years of age and over 1 to 2 tablets
children 6 to under 12 years of age 1 tablet
children under 6 years of age do not use this product in children under 6 years of age
Other Information
  • each tablet contains: calcium 25 mg
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • protect from moisture and light
  • see end flap for expiration date and lot number
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red No 27 aluminum lake, dicalcium phosphate, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Description

Drug Facts

Principal Display Panel

TopCare health Allergy Relief,

100 Tablets

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 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 53414-9

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

Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments?

1-888-333-9792

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
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

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg

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
Purpose

Antihistamine

Directions
  • take every 4 to 6 hours or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years of age and over 1 to 2 tablets
children 6 to under 12 years of age 1 tablet
children under 6 years of age do not use this product in children under 6 years of age
Other Information (Other information)
  • each tablet contains: calcium 25 mg
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • protect from moisture and light
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, D&C red No 27 aluminum lake, dicalcium phosphate, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

TopCare health Allergy Relief,

100 Tablets

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 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 53414-9 (53414-9)

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

Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments? (Questions or comments?)

1-888-333-9792

When Using This Product (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
Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:10.228449 · Updated: 2026-03-14T23:06:34.860555