ALTICOTRON- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops

Alticotron by

Drug Labeling and Warnings

Alticotron by is a Otc medication manufactured, distributed, or labeled by Alternative Pharmacal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each 1 mL)                Purpose

Dextromethorphan HBr............ 5 mg............. Cough Suppressant

Guaifenesin.......................... 100 mg............. Expectorant

Phenylephrine HCl................ 2.5 mg.............. Nasal Decongestant 

PURPOSE

Cough Suppressant

Expectorant

Nasal Decongestant

INDICATIONS & USAGE

Uses

• non-narcotic cough suppreassant which temporarily calms due to minor throat and bronchial irritation as may occur with common cold
• helps decongest sinus openings and passages; temporarily relieves sinus openings and passages; temporarily relieves sinus congestion and pressur
• helps lossen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
• temporarily relieves nasal congestion due to the common cold
• helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure

WARNINGS

Warnings

a persistant cough may be sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

DO NOT USE

If a child is 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 child's prescription drug that contains MAOI; ask your doctor or pharmacist before taking this product.

Ask a doctor before use if the child has:

• Heart disease
• High blood pressure 
• Thyroid deases
• Diabetes
• Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or where cough is accompanied by excessive phlegm (mucus)

When using this product do not exceed recommended dosage.

Stop use and ask a doctor before use if:

• your child gets nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health profession before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions 

• Do not use more than 6 doses in any 24 hour period
• Repeat every 4 hours
• Measure with dosage device provided. Do not use with any other device

• Children 6 years to under 12 years of age: 2 ml
• Children 2 years to under 6 years of age: Ask a doctor
• Children under 2 years of age: Ask a doctor

OTHER SAFETY INFORMATION

Other Information

Store at room temperature 150 - 300C (590-860F)

Tamper Evident Feature: Do not use if seal is torn, broken or missing. Avoid excessive heat or humidity.

INACTIVE INGREDIENT

Inactiveingredients

 citric acid, grape flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, and sucralose

QUESTIONS

Questions or comments? 1-786-507-1566

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALTICOTRON 
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53163-107
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 1 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53163-107-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2015

Labeler - Alternative Pharmacal Corporation (078528214)