Label: DEXCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 66576-080-01 - Packager: Syntho Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 3, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients (in each tablet)
- Inactive ingredients
- Purpose
- Uses
-
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?
- KEEP OUT OF REACH OF CHILDREN
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DEXCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL
dexchlorpheniramine maleate, phenylephrine hcl tabletProduct 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)
