439 - nighttime sleep aid

439 - nighttime sleep aid
SPL v3
SPL
SPL Set ID 3761182c-275b-40f3-a262-9ef5f5a80723
Route
oral
Published
Effective Date 2023-03-16
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 potato

Identifiers & Packaging

Pill Appearance
Imprint: 44;386 Shape: oval Color: blue Size: 10 mm Score: 1
Marketing Status
anda active Since 2023-05-16

Purpose

Nighttime sleep-aid

Description

Doxylamine succinate 25 mg


Medication Information

Purpose

Nighttime sleep-aid

Other Information
  • DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • store at controlled room temperature 20°– 25°C (68°– 77°F)
  • use by expiration date on package

Inactive Ingredients

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

cellulose, sodium starch glycolate

Description

Doxylamine succinate 25 mg

Principal Display Panel

Nighttime sleep aid


 

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

Use(s)

helps to reduce difficulty in falling asleep

Questions

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

Do Not Use
  • in children under 12 years of age

Active Ingredient(s)

Doxylamine succinate 25 mg

When Using This Product
  • avoid alcoholic beverages
  • take only at bedtime

Ask A Doctor Before Use If

you have 

  • 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

Purpose

Nighttime sleep-aid

Other Information (Other information)
  • DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • store at controlled room temperature 20°– 25°C (68°– 77°F)
  • use by expiration date on package

Inactive Ingredients (Inactive ingredients)

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

cellulose, sodium starch glycolate

Principal Display Panel

Nighttime sleep aid


 

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

Use(s)

helps to reduce difficulty in falling asleep

Questions

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

Do Not Use (Do not use)
  • in children under 12 years of age

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

Doxylamine succinate 25 mg

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)

you have 

  • 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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