DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE tablet

Doxylamine Succinate and Phenylephrine Hydrochloride by

Drug Labeling and Warnings

Doxylamine Succinate and Phenylephrine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Westminster Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

Active ingredients (in each tablet)	Purpose
Doxylamine Succinate 7.5mg	Antihistamine
Phenylephrine HCl 10mg	Nasal Decongestant

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• nasal congestion
• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• trouble urinating due to enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis

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

When using this product

• exctability may occur, especially in children
• may cause marked drowsiness
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase the drowsiness effect
• use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or are accompanied by fever

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

Keep out of reach of children.

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In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed recommended dosage.

• Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours.
• Children 6 to 12 years of age: 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours.
• Children 6 years of age and under: Consult a physician.

Other Information

Store at 15°-30°C (59°-86°F)

Supplied in a tight, light-resistant container with a child-resistant cap. Doxylamine Succinate and Phenylephrine HCl tablets are light blue, caplet shaped, scored tablets, debossed "WP" bisect "199" on one side and plain on the other.

Inactive ingredients

FD&C Blue #2, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Sodium Starch Glycolate

Questions? Comments?

Call 1-844-221-7294

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC: 69367-199-01

Doxylamine Succinate
and Phenylephrine HCl

Antihistamine Nasal Decongestant

Each tablet contains:

Doxylamine Succinate
7.5 mg

Phenylephrine HCl
10 mg

100 Tablets

Westminster
Pharmaceuticals

INGREDIENTS AND APPEARANCE

DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE 
doxylamine succinate and phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69367-199
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	7.5 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	BLUE	Score	2 pieces
Shape	OVAL	Size	14mm
Flavor		Imprint Code	WP;199
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69367-199-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	10/25/2018

Labeler - Westminster Pharmaceuticals, LLC (079516651)