Available Formats

• SPL UNCLASSIFIED SECTION

  Drug Facts

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• Active Ingredients

  (In each 5 mL teaspoonful)

  Brompheniramine Maleate, USP 1 mg

  Dextromethorphan HBr, USP 5 mg

  Phenylephrine HCl, USP 2.5 mg

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• Purpose

  Brompheniramine Maleate Antihistamine

  Dextromethorphan HBr Antitussive (cough suppressant)

  Phenylephrine HCl Nasal decongestant

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• Uses

  Temporarily relieves these symptoms due to hay fever (allergic rhinitis):

  • cough due to minor throat and bronchial irritation
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily restores freer breathing through the nose

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• Warnings

  Do not use

  • to sedate a child or make a child sleepy
  • 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 drug.

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• Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)

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• Ask a doctor or pharmacist before use if you are

  • taking any other nasal decongestant or stimulant
  • taking sedatives or tranquilizers

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• When using this product

  Do not exceed recommended dosage.

  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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• 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.

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• If pregnant or breast-feeding

  ask a health professional before use.

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• Keep out of the reach of children

  In case of overdose, get medical help or contact a Poison Control Center immediately.

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• Directions

  Do not exceed 6 doses in a 24-hour period

  Age	Dose
  Adults and children over 12 years of age:	4 teaspoonsful (20 mL) every 4 hours
  Children 6 to under 12 years of age:	2 teaspoonsful (10 mL) every 4 hours
  Children under 6 years of age:	Ask your doctor

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• Other Information

  • store at 20°-25°C (68°-77°F)
  • very low sodium, contains 1 mg sodium per teaspoonful (5 mL)

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• Inactive Ingredients

  Benzoic acid, edetate disodium, FD&C Red #40, propylene glycol, purified water saccharin sodium, sorbitol solution and strawberry flavoring

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• Questions or Comments

  Call 1-888-527-5522 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com.

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• Principal Display Panel

  Figure 1: 16 oz. Bottle Label

  

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• INGREDIENTS AND APPEARANCE

  ENDACOF DM  brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68047-143 Route of Administration ORAL

  Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 1 mg  in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg  in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg  in 5 mL

  Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM)   EDETATE DISODIUM (UNII: 7FLD91C86K)   FD&C RED NO. 40 (UNII: WZB9127XOA)   PROPYLENE GLYCOL (UNII: 6DC9Q167V3)   WATER (UNII: 059QF0KO0R)   SACCHARIN SODIUM (UNII: SB8ZUX40TY)   SORBITOL (UNII: 506T60A25R)

  Product Characteristics Color red Score      Shape Size Flavor STRAWBERRY Imprint Code Contains

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68047-143-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2012

  Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/30/2012

  Labeler - Larken Laboratories, Inc. (149484540)

  Registrant - Larken Laboratories, Inc. (149484540)

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