ENDACOF DC
-
codeine phosphate and
pseudoephedrine hydrochloride liquid
Larken Laboratories, Inc.
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EndaCof DCDrug Facts
Active ingredients (in each 5 mL teaspoon)
Codeine Phosphate* …………………….. 10 mg
*(Warning: May be habit-forming)
Pseudoephedrine Hydrochloride ….. 30 mg
Purpose
Codeine Phosphate ……………………….…. Antitussive (Cough Suppressant)
Pseudoephedrine Hydrochloride ............................. Nasal Decongestant
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- reduces the intensity of coughing and suppresses the impulse to cough to help you rest.
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies (allergic rhinitis)
- reduces swelling of nasal passages
- promotes nasal and/or sinus drainage
- relieves sinus congestion and pressure.
Warnings
Do not exceed recommended dosage.
- may cause aggravated constipation
- Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a doctor
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 take this product, unless directed by a doctor before use if you have
- a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- a cough that occurs with too much phlegm (mucus)
- heart disease, diabetes, high blood pressure or thyroid disease
- difficulty in urination due to enlargement of the prostate gland.
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- symptoms do not improve within 7 days or are accompanied by a fever
- cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache; these could be signs of a serious condition.
If pregnant or breastfeeding,
ask a health professional before use.
Keep this and other drugs out of the reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
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 8 teaspoonfuls in a 24 hour period |
| Children 6 to under 12 years of age: | 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls in a 24 hour period. |
| Children 2 to under 6 years of age: | Consult a doctor |
Other information
Store at controlled room temperature, 20°- 25°C (68°-77°F). Protect from freezing
Inactive Ingredients
Bubblegum flavor, Citric Acid, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl
Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose, Tutti-Frutti flavor
Questions or Comments?
Call 1-800-527-5522
PACKAGE LABEL
Figure 1: 16 oz. container label
| ENDACOF
DC
codeine phosphate and pseudoephedrine hydrochloride liquid |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part341 | 10/19/2010 | |
| Labeler - Larken Laboratories, Inc. (791043719) |
| Registrant - Larken Laboratories, Inc. (791043719) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| TG United Liquid, Inc. | 830980947 | MANUFACTURE | |