Yyba - Welmate - Sleep Aid Tablets, 25 Mg(73581-205)

Yyba - Welmate - Sleep Aid Tablets, 25 Mg(73581-205)
SPL v8
SPL
SPL Set ID a436f6d2-6d7e-4f0e-b1c3-acc17cbcb64a
Route
ORAL
Published
Effective Date 2025-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Doxylamine (25 mg)
Inactive Ingredients
Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A

Identifiers & Packaging

Pill Appearance
Imprint: 44;386 Shape: oval Color: blue Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2021-08-03

Description

Doxylamine Succinate 25 mg

Purpose

Night sleep-aid


Medication Information

Purpose

Night sleep-aid

Description

Doxylamine Succinate 25 mg

Uses

Helps to reduce difficulty in falling asleep

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 51945-4

Warnings

Ask a doctor before use if you have.

  • a breathing problem such as asthma, emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate glad
  • glucoma

Ask a doctor or pharmacist before use if you are taking any other drugs.

When usinf this product

  • avoid alcohol beverages
  • take only at bedtime

Stop use and ask a doctor if sleeplessness persists continuosly for more than two weeks. Insomnia may be s symptom of serious underlying medical illness.

If pregnant of breast-feeding, as a health professional before use.

Directions
  • adults and children 12 years and older:

take one tablet 30 minutes before going to bed; take one daily or as directed by a doctor

  • children under 12 years:

do not use

Questions?

call toll-free 1-866-933-6337

Other Information
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
Inactive Ingredients

dicalcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Active Ingredient (in Each Tablet)

Doxylamine Succinate 25 mg


Structured Label Content

Uses

Helps to reduce difficulty in falling asleep

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 51945-4 (51945-4)

Purpose

Night sleep-aid

Warnings

Ask a doctor before use if you have.

  • a breathing problem such as asthma, emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate glad
  • glucoma

Ask a doctor or pharmacist before use if you are taking any other drugs.

When usinf this product

  • avoid alcohol beverages
  • take only at bedtime

Stop use and ask a doctor if sleeplessness persists continuosly for more than two weeks. Insomnia may be s symptom of serious underlying medical illness.

If pregnant of breast-feeding, as a health professional before use.

Directions
  • adults and children 12 years and older:

take one tablet 30 minutes before going to bed; take one daily or as directed by a doctor

  • children under 12 years:

do not use

Questions?

call toll-free 1-866-933-6337

Other Information (Other information)
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
Inactive Ingredients (Inactive ingredients)

dicalcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

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

Doxylamine Succinate 25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)