LODRANE D
-
brompheniramine maleate and
pseudoephedrine hydrochloride capsule
ECR Pharmaceuticals
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.
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Each green and white, LODRANE D capsule contains:
Brompheniramine maleate ............... 4 mg
Pseudoephedrine hydrochloride .... 60 mg
In an immediate release formulation.
LODRANE D capsules are indicated for the temporary relief of symptoms associated with allergic rhinitis, including runny nose, sneezing, itching of the nose or throat, itchy watery eyes, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies. Promotes nasal and/or sinus drainage.
Do not exceed recommended dosage. Do not use if you have had an allergic reaction to any of the ingredients in this product. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. Do not use 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. May cause excitability especially in children. Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis. May cause drowsiness. Alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use Caution when driving a motor vehicle or operating machinery. Do not give this product to children under 12 years except under the advice and supervision of a physician. If pregnant or breast feeding ask a healthcare professional before use.
LODRANE D Capsules: Adults and children over 12 years of age: One capsule every 4 to 6 hours, not to exceed 4 capsules in 24 hours.
LODRANE D Capsules: Bottles of 60 Capsules (NDC 00095-0860-06). Each green and white capsule is imprinted “860”.
Manufactured for:
ECR Pharmaceuticals
Richmond, Virginia 23255
MI 0860
Rev. 6/2011
OE1280
NDC 00095-0860-06
60 Capsules
LODRANE® D Capsules
EACH CAPSULE CONTAINS:
Brompheniramine maleate ............... 4 mg
Pseudoephedrine hydrochloride .... 60 mg
In an immediate release formulation.
USUAL DOSAGE: Adults and Children Over 12:
1 Capsule every 4-6 hours.
Do not exceed 4 capsules in 24 hours.
For additional information, see accompanying product literature.
KEEP THIS AND ALL MEDICATIONS
OUT OF THE REACH OF CHILDREN.
Store at room temperature.
Manufactured for:
ECR Pharmaceuticals
Richmond, Virginia 23255
ML 0860 LE2127 Rev. 06/2011
LODRANE D
brompheniramine maleate and pseudoephedrine hydrochloride capsule |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part341 | 10/21/2011 |
Labeler - ECR Pharmaceuticals (831116350) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Elite Laboratories Inc | 785398728 | MANUFACTURE |
Revised: 11/2011 ECR Pharmaceuticals