Allergy (ld/ck)

Allergy (ld/ck)
SPL v3
SPL
SPL Set ID d1f370ac-e7f4-baf7-e053-2995a90a1e50
Route
ORAL
Published
Effective Date 2021-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
D&c Red No. 27 Aluminum Lake Dibasic Calcium Phosphate Dihydrate Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Starch, Corn Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;329 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-12

Description

Active ingredient (in each tablet) Diphenhydramine HCl 25 mg


Medication Information

Description

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
  • itching of the nose or throat
  • sneezing
  • temporarily relieves these symptoms due to the common cold:
  • runny nose
  • sneezing
Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product

  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution 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 are taking sedatives or tranquilizers.

Section 50569-3

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
Section 50570-1

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Section 51945-4

[caduceus] *Compare to the Active Ingredient

in Benadryl ® Allergy ULTRATAB ® Tablets

Allergy

Diphenhydramine HCI 25 mg

Antihistamine



Relieves

• Runny Nose • Sneezing
[tablet image]

• Itchy, Watery Eyes ACTUAL SIZE

• Itchy Nose or Throat

36

Tablets
[Lil' Drug Store logo]

Section 53414-9

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

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Directions
  • do not take more than directed
  • 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 and over
1 to 2 tablets
children 6 to under 12

years
1 tablet
children under 6 years do not use

Other Information
  • each tablet contains: calcium 30 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number
Inactive Ingredients

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments?

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


Structured Label Content

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

Section 50567-7 (50567-7)

When using this product

  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution 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 are taking 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
  • difficulty in urination due to enlargement of the prostate gland
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 51945-4 (51945-4)

[caduceus] *Compare to the Active Ingredient

in Benadryl ® Allergy ULTRATAB ® Tablets

Allergy

Diphenhydramine HCI 25 mg

Antihistamine



Relieves

• Runny Nose • Sneezing
[tablet image]

• Itchy, Watery Eyes ACTUAL SIZE

• Itchy Nose or Throat

36

Tablets
[Lil' Drug Store logo]

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Directions
  • do not take more than directed
  • 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 and over
1 to 2 tablets
children 6 to under 12

years
1 tablet
children under 6 years do not use

Other Information (Other information)
  • each tablet contains: calcium 30 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

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


Advanced Ingredient Data


Raw Label Data

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