439- Nighttime Sleep Aid

439- Nighttime Sleep Aid
SPL v9
SPL
SPL Set ID d91f0c21-28f0-4d32-a1d2-fae406b90bf7
Route
ORAL
Published
Effective Date 2023-07-25
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 Potato

Identifiers & Packaging

Pill Appearance
Imprint: 44;386 Shape: oval Color: blue Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2023-10-31

Description

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Doxylamine succinate 25 mg

Use(s)

helps to reduce difficulty in falling asleep

Directions

Adults and children 12 years and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a

doctor

Children under 12 years of age: do not use

Do Not Use
  • in children under 12 years of age
Other Information
  • Do not use if blister unit is broken or torn
  • store at controlled room temperature 20°– 25°C (68°– 77°F)
  • use by expiration date on package
Questions/comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Active Ingredient(s)

Doxylamine succinate 25 mg

Inactive Ingredients

dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate,

microcrystalline cellulose, sodium starch glycolate

Principal Display Panel
Sleep Aid
When Using This Product
  • avoid alcoholic beverages
  • take only at bedtime



Ask A Doctor Before Use If
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to an enlargement of the prostate gland
Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of

a serious underlying medical illness.

If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Or Pharmacist Before Use If

you are taking any other drugs.


Structured Label Content

Use(s)

helps to reduce difficulty in falling asleep

Purpose

Nighttime sleep-aid

Directions

Adults and children 12 years and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a

doctor

Children under 12 years of age: do not use

Do Not Use (Do not use)
  • in children under 12 years of age
Other Information (Other information)
  • Do not use if blister unit is broken or torn
  • store at controlled room temperature 20°– 25°C (68°– 77°F)
  • use by expiration date on package
Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Active Ingredient(s) (Active ingredient(s))

Doxylamine succinate 25 mg

Inactive Ingredients (Inactive ingredients)

dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate,

microcrystalline cellulose, sodium starch glycolate

Principal Display Panel
Sleep Aid
When Using This Product (When using this product)
  • avoid alcoholic beverages
  • take only at bedtime



Ask A Doctor Before Use If (Ask a doctor before use if)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to an enlargement of the prostate gland
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of

a serious underlying medical illness.

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you are taking any other drugs.


Advanced Ingredient Data


Raw Label Data

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