Circle K ™

Circle K ™
SPL v8
SPL
SPL Set ID a6a1e3d9-575c-4adf-beb6-c9719de55c67
Route
ORAL
Published
Effective Date 2019-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Croscarmellose Sodium D&c Red No. 27 Anhydrous Dibasic Calcium Phosphate Hypromellose, Unspecified Lactose, Unspecified Form Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 048;D Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2014-11-01 Until 2024-04-14

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
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 tranquilizers or sedatives.

Section 53414-9

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

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 and over take 1 to 2 tablets
children 6 to under 12 years take 1 tablet
children under 6 years do not use
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • each tablet may contain: calcium 25 mg
  • store at room temperature 68°-77°F (20°-25°C)
  • protect from light and moisture
Inactive Ingredients

carnauba wax

, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate
, hypromellose, lactose
, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80
, titanium dioxide

Questions Or Comments?

Call toll-free 1-877-507-6516 (M-F 8AM – 4:30PM CST)

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
Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25 mg

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
Principal Display Panel 4 Tablet Pouch Carton Ndc 66715 5654 2

Compare to the Active Ingredient

in Benadryl® Allergy**

CIRCLE K

Allergy

Diphenhydramine HCl 25 mg, Antihistamine

ACTUAL SIZE

Relieves

  • Runny Nose - Sneezing
  • Itchy, Watery Eyes
  • Itchy Nose or Throat

4 Tablets

2 POUCHES, 2 TABLETS PER POUCH

Principal Display Panel 6 Tablet Pouch Carton Ndc 66715 5554 3

RELIEVES SYMPTOMS OF HAY FEVER & OTHER ALLERGIES

Compare to the active ingredient in

Benadryl® Allergy ULTRATABS®**

CIRCLE K™

multi-symptom

allergy

Diphenhydramine HCl 25 mg,

Antihistamine

[tablet image]

actual size

6 tablets (2 per pouch)


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
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 tranquilizers or sedatives.

Section 53414-9 (53414-9)

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

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 and over take 1 to 2 tablets
children 6 to under 12 years take 1 tablet
children under 6 years do not use
Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • each tablet may contain: calcium 25 mg
  • store at room temperature 68°-77°F (20°-25°C)
  • protect from light and moisture
Inactive Ingredients (Inactive ingredients)

carnauba wax

, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate
, hypromellose, lactose
, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80
, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call toll-free 1-877-507-6516 (M-F 8AM – 4:30PM CST)

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
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg

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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
Principal Display Panel 4 Tablet Pouch Carton Ndc 66715 5654 2 (PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton - NDC 66715-5654-2)

Compare to the Active Ingredient

in Benadryl® Allergy**

CIRCLE K

Allergy

Diphenhydramine HCl 25 mg, Antihistamine

ACTUAL SIZE

Relieves

  • Runny Nose - Sneezing
  • Itchy, Watery Eyes
  • Itchy Nose or Throat

4 Tablets

2 POUCHES, 2 TABLETS PER POUCH

Principal Display Panel 6 Tablet Pouch Carton Ndc 66715 5554 3 (PRINCIPAL DISPLAY PANEL - 6 Tablet Pouch Carton - NDC 66715-5554-3)

RELIEVES SYMPTOMS OF HAY FEVER & OTHER ALLERGIES

Compare to the active ingredient in

Benadryl® Allergy ULTRATABS®**

CIRCLE K™

multi-symptom

allergy

Diphenhydramine HCl 25 mg,

Antihistamine

[tablet image]

actual size

6 tablets (2 per pouch)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)