Multi Symptom Cold CF

Manufacturer
FAZ Marketing
Effective date
2019-10-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:03:38

Label at a glance#

ProductMulti Symptom Cold CF
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 10 mg / Dextrometorfano HBr 10

Guaifenesin 200 mg / Guaifenesina 200 mg

Phenylephrine HCl 5 mg / Fenilefrina HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other oral nasal decongestant or stimulant.

When using this product,

OTC - WHEN USING SECTION

do not use more than directed.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Histiacil Multi-Symptom Cold CF
Histiacil Multi-Symptom Cold CF

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH2
GUAIFENESINACTIVE INGREDIENT495W7451VQ2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS2
GUAIFENESINACTIVE MOIETY495W7451VQ2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3A2
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQ2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
SORBITOLINACTIVE INGREDIENT506T60A25R2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD42
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95K2
WATERINACTIVE INGREDIENT059QF0KO0R2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50061-41250061-412-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 459 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY, METERED / NASAL1.2 mg/1mlExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
29 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET / SUBLINGUAL36 mgExact identifier — unii candidate
61 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RAEROSOL, FOAM / TOPICAL4.95 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION, SOLUTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQINJECTION / INTRAVENOUS16950 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii candidate
35 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii candidate
22 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ASOLUTION / DENTALNAExact identifier — unii candidate
24 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / TOPICAL186 mgExact identifier — unii candidate
47 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii candidate
22 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KCREAM / TOPICAL2 mgExact identifier — unii candidate
47 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPASTE / ORAL26 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS414 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii candidate
28 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQTABLET / ORAL1 mgExact identifier — unii candidate
13 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLFILM / BUCCAL9 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRAVENOUS1152 mgExact identifier — unii candidate
61 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KINJECTION / SUBCUTANEOUS75 mgExact identifier — unii candidate
47 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii candidate
22 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / SUBCUTANEOUS101 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ATABLET / SUBLINGUAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii candidate
29 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRAMUSCULAR101 mgExact identifier — unii candidate
61 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KSHAMPOO / TOPICAL186 mgExact identifier — unii candidate
47 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii candidate
29 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KCAPSULE / ORAL35 mgExact identifier — unii candidate
47 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KPOWDER, FOR SUSPENSION / ORAL5010 mgExact identifier — unii candidate
47 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SUSPENSION / ORAL570 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLOTION / TOPICAL10.7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / OPHTHALMIC6 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KTABLET, CHEWABLE / ORAL14 mgExact identifier — unii candidate
47 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii candidate
24 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bee0c5f3-d1b0-4d99-a6c3-7dcbef1bc2473c59bc72-2169-419c-a2dc-5346d7ff918f2019-10-31WarningsExact identifier
spl id: bee0c5f3-d1b0-4d99-a6c3-7dcbef1bc247
spl set id: 3c59bc72-2169-419c-a2dc-5346d7ff918f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.