SPL v8
SPL
SPL Set ID acdc8740-6231-d1e8-e053-2995a90a3b8d
Route
ORAL
Published
Effective Date 2024-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Doxylamine (9.78 mg)
Inactive Ingredients
Crataegus Laevigata Fruit Oat Water Citric Acid Monohydrate Glycerin Passiflora Incarnata Flowering Top Sucrose Aesculus Hippocastanum Seed Oil Honey Potassium Sorbate Tragacanth Vanilla Viscum Album Fruiting Top Eschscholzia Californica Hops

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-10

Description

Each 3 mL dose contains Doxylamine succinate 9.78 mg

Purpose

Doxylamine succinate 9.78 mg.........Antihistamine


Medication Information

Purpose

Doxylamine succinate 9.78 mg.........Antihistamine

Description

Each 3 mL dose contains Doxylamine succinate 9.78 mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat

Section 43683-2

Directions - 8/2024

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
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Section 50568-5

Ask a doctor or pharmacist before useif you are taking sedatives or tranquilizers.

Section 50569-3

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty urinating due to an enlarged prostate gland
Section 51945-4

sambrosa

sweet dreams

Night Syrup

For allergy relief to have a good night's rest

With Doxylamine (antihistamine) 9.78 mg

In a great-tasting base of honey and 7 organic herbs.

300mL

10.14 fl oz

Alcohol 3% vol.

Section 53414-9

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

Section 55106-9

Each 3 mL dose contains Doxylamine succinate 9.78 mg

Directions
  • take only as directed
  • always use the provided measurement spoon. A full spoon equals 3mL.
  • adults and children 12 years of age and over: oral dosage is 3 mL every 4 to 6 hours, not to exceed 18 mL in 24 hours, or as directed by a doctor.
  • children under 12 years of age: consult a doctor.
Other Information

store in a refrigerator after opening at 35-41 degrees F (2-5 degrees C)

Inactive Ingredients

Citric Acid, Glycerin, Herbal alcohol-water extract blend from 7 organic herbs(California Poppy, Hawthorn, Hops, Mistletoe, Oat, Passion flower, White chestnut) Honey, Potassium Sorbate, Sugar, Tragacanth, Vanilla, and Water.


Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat

Section 43683-2 (43683-2)

Directions - 8/2024

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
  • be careful 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 useif you are taking sedatives or tranquilizers.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty urinating due to an enlarged prostate gland
Section 51945-4 (51945-4)

sambrosa

sweet dreams

Night Syrup

For allergy relief to have a good night's rest

With Doxylamine (antihistamine) 9.78 mg

In a great-tasting base of honey and 7 organic herbs.

300mL

10.14 fl oz

Alcohol 3% vol.

Section 53414-9 (53414-9)

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

Section 55106-9 (55106-9)

Each 3 mL dose contains Doxylamine succinate 9.78 mg

Purpose

Doxylamine succinate 9.78 mg.........Antihistamine

Directions
  • take only as directed
  • always use the provided measurement spoon. A full spoon equals 3mL.
  • adults and children 12 years of age and over: oral dosage is 3 mL every 4 to 6 hours, not to exceed 18 mL in 24 hours, or as directed by a doctor.
  • children under 12 years of age: consult a doctor.
Other Information

store in a refrigerator after opening at 35-41 degrees F (2-5 degrees C)

Inactive Ingredients

Citric Acid, Glycerin, Herbal alcohol-water extract blend from 7 organic herbs(California Poppy, Hawthorn, Hops, Mistletoe, Oat, Passion flower, White chestnut) Honey, Potassium Sorbate, Sugar, Tragacanth, Vanilla, and Water.


Advanced Ingredient Data


Raw Label Data

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