MULTI SYMPTOM COLD DOUBLE MAX POWER- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Multi Symptom Cold by

Drug Labeling and Warnings

Multi Symptom Cold by is a Otc medication manufactured, distributed, or labeled by FAZ Marketing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL)

Dextromethorphan HBr 10 mg / Dextrometorfano HBr 10

Guaifenesin 200 mg / Guaifenesina 200 mg

Phenylephrine HCl 5 mg / Fenilefrina HCl 10 mg

Purposes

Cough suppressant

Expectorant

Nasal decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
• temporarily relieves these symptoms occurring with a cold:
  • nasal congestion
  • cough due to minor throat and bronchial irritation

Warnings

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.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking any other oral nasal decongestant or stimulant.

When using this product,

do not use more than directed.

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• 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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• shake well before using
• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided
• keep dosing cup with product
• this adult product is not intended for use in children under 12 years of age
• tsp = teaspoon, mL = milliliter
• adults and children 12 years and over - 2 tsp (10 mL) every 4 hours
• children under 12 years - do not use

Other information

• store at 20º-25°C (68º-77°F). Do not refrigerate.

Inactive ingredients

artificial flavor/sabores artificiales, citric acid/acido citrico, FD&C red #40/FD&C rojo #40, glycerin/glicerina, menthol/mentol, polyethylene glycol 300/polietilen glicol 300, propylene glycol/propilen glicol, purified water/agua purificada, sodium benzoate/benzoato de sodio, sodium citrate/citrato de sodio, sorbitol, sucralose/sucralosa, xanthan gum/goma de xantano

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Adults For Ages 12 & Over Non-Drowsy

Multi Symptom Cold

DOUBLE MAX POWER

• Severe Cough
• Nasal Congestion
• Chest Congestion

Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl

Cough Suppressant / Expectorant / Nasal Decongestant

FL OZ (mL)

DOSAGE CUP INCLUDED

Product of U.S.A.

Distributed by Midway Importing, Inc.

1807 Brittmore Road

Houston, TX 77043

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL ON THE BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

PARENTS: Learn about teen medicine abuse

www.StopMedicineAbuse.org

Package Label

Histiacil Multi Symptom Cold Double Max Power Liquid

 

INGREDIENTS AND APPEARANCE

MULTI SYMPTOM COLD  DOUBLE MAX POWER
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50061-381
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50061-381-04	1 in 1 BOX	06/01/2014	12/31/2020
1		118 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	06/01/2014	12/31/2020

Labeler - FAZ Marketing (625680645)