Label: ED A-HIST- chlorpheniramine/phenylephrine liquid
- NDC Code(s): 0485-0155-16
- Packager: Edwards Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 13, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
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Warnings: Do not exceed recommended dosage.
Do not use this product
- if you are now taking prescription monaimine 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 know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Do not take this product, unless directed by a doctor before use if you have
- A breathing problem such as emphysema or chronic bronchitis
- Glaucoma, heart disease, diabetes, high blood pressure or thyroid disease
- Difficulty in urination due to enlargement of the prostate gland
When using the product
- May cause drowsiness
- 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.
- if you are now taking prescription monaimine 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 know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
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Directions
Do not exceed recommended dosage.
Adults and children 12 years of age and over: 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in a 24 hour period Children 6 to under 12 years of age:
1/2 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in a 24 hour period Children under 6 years of age: Consult a Doctor A special measuring device should be used to give an accurate dose of this product to children under 12 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.
- Other information:
- Inactive ingredients:
- Questions or comments?
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Product Packaging
The packaging below represents the labeling currently used:
Principal display panel and side panel for 473 mL label:
NDC 0485-0155-16
ED A-HIST LIQUID
ANTIHISTAMINE / DECONGESTANT
Each 5 mL (one teaspoonful) for oral administration contains:
Chlorpheniramine Maleate..............................4 mg
Phenyleprhing Hydrochloride.........................10 mg
Alcohol USP.....................................................5%GLUTEN FREE / SUGAR FREE
DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING
Manufactured for:
EDWARDS Pharmaceuticals, Inc.
Ripley, MS 38663Net Contents: 1 pint (473 mL)
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
dispense in a tight, light-resistant container with a child-resistant closure.
This bottle is not to be dispensed to consumer.
Manufactured for: Edwards Pharmaceuticals, Inc., Ripley, MS 38663Iss. 12/10
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INGREDIENTS AND APPEARANCE
ED A-HIST
chlorpheniramine/phenylephrine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0485-0155 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0485-0155-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/11/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/11/2011 Labeler - Edwards Pharmaceuticals, Inc. (195118880) Establishment Name Address ID/FEI Business Operations Syntho Pharmaceuticals 088797407 manufacture(0485-0155)