Label: ED CHLORPED JR- chlorpheniramine maleate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0485-0098-04, 0485-0098-16 - Packager: EDWARDS 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 October 10, 2022
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- Active Ingredients (in each 5 mL teaspoonful)
- Purpose
- Uses
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Warnings
Do not exceed recommended dosage.
Do not take this product, unless directed by a doctor, if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.
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Directions
Do not exceed recommended dosage.
Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 12 teaspoonfuls in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor
- Other information
- Inactive ingredients
- Question? Comments?
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PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
ED Chlorped Jr.
E
NDC 0485-0098-16
ED Chlorped Jr.
ANTIHISTAMINE
FOR PROFESSIONAL USE ONLY
Sugar Free • Alcohol Free
Each teaspoonful (5 mL)
for oral administration contains:
Chlorpheniramine Maleate 2 mgCherry Flavor
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or
missing.Manufactured for:
EDWARDS
Pharmaceuticals, Inc.
Ripley, MS 3866316oz. (473 mL)
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INGREDIENTS AND APPEARANCE
ED CHLORPED JR
chlorpheniramine maleate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0485-0098 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) METHYLPARABEN (UNII: A2I8C7HI9T) GLYCERIN (UNII: PDC6A3C0OX) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0485-0098-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/04/2011 2 NDC:0485-0098-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/04/2011 09/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/04/2011 Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)