Label: ED A-HIST- chlorpheniramine/phenylephrine liquid
- NDC Code(s): 0485-0155-16
- Packager: Edwards Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated January 13, 2024
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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)