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NDC 00485-0171-16 ED A-HIST DM 4; 15; 10 mg/5mL; mg/5mL; mg/5mL Details
ED A-HIST DM 4; 15; 10 mg/5mL; mg/5mL; mg/5mL
ED A-HIST DM is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by EDWARDS PHARMACEUTICALS, INC.. The primary component is CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 00485-0171-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 00485-0171-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 00485-0171-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00485-0171 |
|---|---|
| Product ID | 0485-0171_a8ccc98b-2b69-4a3a-a608-996a3585b296 |
| Associated GPIs | 43995803120930 |
| GCN Sequence Number | 051896 |
| GCN Sequence Number Description | chlorpheniramine/phenyleph/DM LIQUID 4-10-15/5 ORAL |
| HIC3 | B3R |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
| GCN | 19347 |
| HICL Sequence Number | 000375 |
| HICL Sequence Number Description | CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE HCL/DEXTROMETHORPHAN |
| Brand/Generic | Generic |
| Proprietary Name | ED A-HIST DM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 4; 15; 10 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | EDWARDS PHARMACEUTICALS, INC. |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Rece |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 00485-0171-16 (00485017116)
| NDC Package Code | 0485-0171-16 |
|---|---|
| Billing NDC | 00485017116 |
| Package | 473 mL in 1 BOTTLE, PLASTIC (0485-0171-16) |
| Marketing Start Date | 2012-09-11 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.06194 |
| Pricing Unit | ML |
| Effective Date | 2024-01-17 |
| NDC Description | ED-A-HIST DM LIQUID |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL e0e2b117-62bc-4132-9f7c-fe2a912052b1 Details
SPL UNCLASSIFIED SECTION
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.
Do not use this product, unless directed by a doctor, if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- a persistent or chronic cough that occurs with too much phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- diabetes mellitus
- 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.
When using this product
- excitability may occur, especially in children
- may cause marked drowsiness
- sedatives and tranquilizers may increase drowsiness effect
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
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 24 hours, or as directed by a doctor. |
| Children 6 to under 12 years of age: | 1/2 teaspoonful (2.5 mL) every 4 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a doctor. |
| Children under 6 years of age: | Consult a doctor. |
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
E
NDC 0485-0171-16
ED A-HIST DM
Antihistamine • Antitussive
• Nasal Decongestant
Sugar Free • Gluten Free
Each teaspoonful (5 mL)
for oral administration contains:
Chlorpheniramine Maleate 4 mg
Dextromethorphan HBr 15 mg
Phenylephrine HCl 10 mg
Banana 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 38663
16oz. (473 mL)
INGREDIENTS AND APPEARANCE
| ED A-HIST DM
dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride liquid |
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| Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880) |