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

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

Description

Active ingredient (in each tablet) Diphenhydramine HCl 25 mg

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

Questions Or Comments?

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


Structured Label Content

Active Ingredient (55106-9)

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
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

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

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

All Sections (JSON)