Label: EXEFEN IR - guaifenesin and pseudoephedrine hydrochloride tablet
- NDC Code(s): 68047-157-01
- Packager: Larken Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
- Active Ingredients (in each tablet )
Guaifenesin, USP 400 mg
Pseudoephedrine HCl, USP 60 mgClose
Guaifenesin, USP Expectorant
Pseudoephedrine HCl, USP Nasal decongestantClose
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies (allergic rhinitis)
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- temporarily relieves sinus congestion and pressure
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 two 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 drug.Close
- Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by excessive phlegm (mucus)
- When using this product
do not exceed the recommended dosageClose
- Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur.
- 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 breast-feeding,
ask a health professional before use.Close
- Keep out of the reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.Close
- Do not exceed 4 doses in a 24 hour period
- Adults and children 12 years of age and over: 1 tablet every 4 hours.
- Children 6 to under 12 years of age: 1/2 tablet every 4 hours.
- Other information
- store at 20°- 25°C (68°- 77°F)
- tamper evident: do not use if foil seal under the cap is broken or missing.
- contains 4 mg sodium in each tablet
- contains less than 1 mg magnesium in each tablet
- Inactive Ingredients
croscarmellose sodium, magnesium stearate (veg), microcrystalline cellulose, povidone, sodium starch glycolate and starch.Close
- Questions or Comments
Call 1-888-527-5522 weekdays from 9 AM to 4 PM CST or go to http://www.larkenlabs.comClose
- Package Label
100 ct Label Rev. 11/2012
- INGREDIENTS AND APPEARANCE
guaifenesin and pseudoephedrine hydrochloride tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68047-157 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE Score 2 pieces Shape CAPSULE Size 18mm Flavor Imprint Code LL157 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68047-157-01 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/10/2011 Labeler - Larken Laboratories, Inc. (791043719) Establishment Name Address ID/FEI Business Operations Sovereign Pharmaceuticals, LLC 623168267 MANUFACTURE(68047-157)