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

Disclaimer: Most OTC drugs are not reviewed and approved by 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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Drug Facts

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

Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg

Histiacil Multi Symptom Cold Double Max Power Liquid

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	06/01/2014	12/31/2020

Labeler - FAZ Marketing (625680645)

Revised: 10/2019

Document Id: 4bfd539e-9473-4f53-a3ec-f4da24386299

Set id: 162a7d4f-8e3f-4fe3-9c08-30bb54032fae

Version: 3

Effective Time: 20191031

FAZ Marketing