DEXCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL tablet

Dexchlorpheniramine Maleate, Phenylephrine HCl by

Drug Labeling and Warnings

Dexchlorpheniramine Maleate, Phenylephrine HCl by is a Otc medication manufactured, distributed, or labeled by Syntho Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each tablet)

1. Dexchlorpheniramine Maleate - 2 mg
2. Phenylephrine HCl - 10 mg

Inactive ingredients

Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate, Purified Water, PEG, HPMC

Purpose

1. Dexchlorpheniramine Maleate 2 mg -  Antihistamine
2. Phenylephrine HCl 10 mg - Nasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
■ runny nose
■ sneezing
■ itching of the nose or throat
■ itchy, watery eyes
■ nasal congestion
■ 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
■ a breathing problem such as emphysema or chronic bronchitis
■ glaucoma 
■ heart disease
■ high blood pressure 
■ thyroid disease
■ diabetes mellilus
■ difficulty in urination due to enlargement of the prostate gland

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

When using this product
■ excitability may occur, especially in children
■ may cause drowsiness
■ alcohol, sedatives and tranquilizers may increase the drowsiness effect
■ avoid alcoholic beverages
■ 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 a fever
■ new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

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, or as directed by a doctor
• Children 6 to under 12 years of age: 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor
• Children under 6 years of age: Consult a doctor.

Questions or Comments?

Call 1-800-664-1490

KEEP OUT OF REACH OF CHILDREN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rymed Tablets - NDC: 66576-080-01 - 100's Bottle Label

INGREDIENTS AND APPEARANCE

DEXCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL 
dexchlorpheniramine maleate, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66576-080
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	10 mg
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N)	DEXCHLORPHENIRAMINE MALEATE	2 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	12mm
Flavor		Imprint Code	ED;DM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66576-080-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/02/2022

Labeler - Syntho Pharmaceuticals Inc. (088797407)

Registrant - Syntho Pharmaceuticals Inc. (088797407)

Establishment
Name	Address	ID/FEI	Business Operations
Syntho Pharmaceuticals Inc.		088797407	manufacture(66576-080)