Multi Symptom Cold CF by FAZ Marketing Drug Facts

Multi Symptom Cold CF by

Drug Labeling and Warnings

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

Drug Details [pdf]

MULTI SYMPTOM COLD CF- 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: 10 mL every 4 hours
  • children under 12 years: do not use

Other information

  • each 5 mL contains: sodium 3 mg 
  • store at 20º-25°C (68º-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid/acido citrico anhidro, FD&C red#40/FD&C rojo#40, flavor/sabor, glycerin/glicerina, menthol/mentol, polyethylene glycol/polietilen glicol, propylene glycol/propilen glicol, purified water/aqua purificada, sodium benzoate/enzoato de sodio, sorbitol, sucralose/sucralosa, trisodium citrate dihydrate/citrato trisodio dihidrato, 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 CF

Peak 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 PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Package Label

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

Histiacil Multi-Symptom Cold CF

MULTI SYMPTOM COLD CF 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50061-412
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50061-412-041 in 1 BOX12/31/201412/31/2019
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/31/201412/31/2019
Labeler - FAZ Marketing (625680645)

Revised: 10/2019
 
FAZ Marketing