DEXCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL- dexchlorpheniramine maleate, phenylephrine hcl tablet 
Syntho Pharmaceuticals Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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RYMED TABLETS

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Rymed Tablets

DEXCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL 
dexchlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66576-080
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE2 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore2 pieces
ShapeOVALSize12mm
FlavorImprint Code ED;DM
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66576-080-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/02/2022
Labeler - Syntho Pharmaceuticals Inc. (088797407)
Registrant - Syntho Pharmaceuticals Inc. (088797407)
Establishment
NameAddressID/FEIBusiness Operations
Syntho Pharmaceuticals Inc.088797407manufacture(66576-080)

Revised: 11/2022
Document Id: ec8e1b86-9fd7-2534-e053-2a95a90a8bb3
Set id: fe6514a8-353f-4af4-89e7-1e6493f50224
Version: 1
Effective Time: 20221103
 
Syntho Pharmaceuticals Inc.