Bactimicina ®

SPL v6

SPL

SPL Set ID 2e612c62-9bbb-45f2-a253-aa2bfaeaac70

Route

ORAL

Published

Effective Date 2022-11-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Guaifenesin (100 mg) Phenylephrine (5 mg)

Inactive Ingredients

Citric Acid Monohydrate Fd&c Red No. 40 Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sorbitol Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-11-06

Description

Drug Facts

Medication Information

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 43683-2

mL=mililiter;tsp=teaspoonful

Section 50565-1

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

Section 50567-7

When using this product do not use more than directed

Section 50568-5

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

Section 53414-9

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

Section 55105-1

Active ingredients (in each 5 mL = 1 teaspoon)	Purposes
Dextromethorphan HBr, USP 10 mg	Cough Suppressant
Guaifenesin, USP 100 mg	Expectorant
Phenylephrine HCl, USP 5 mg	Nasal Decongestant

Questions

1-800-858-3889

Directions

do not take more than 6 doses in any 24-hour period
this adult product is not intended for children under 12 years old
mL=mililiter;tsp=teaspoonful

Age (years)	Dose
12 and over	2 teaspoons (10 mL) every 4 hours
Under 12	do not use

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.

Other Information

each teaspoon (5 mL) contains: sodium 2 mg
store at 15-30°C (59-86°F)
measure only with dosage cup provided

Principal Display

Triple Action Voltee Para Esponol

TRUSTED SINCE 1978

New Look

Adult Formula

Bactimicina

Ages 12+ Years

Multi-Symptom • Liquid

Cough & Cold

Dextromethorphan HBr (Cough Suppresant)

Guaifenesin (Expectorant)

Phenylephrine HCl (Nasal Decongestant)

Non-Drowsy

Cough • Stuffy Nose

Chest Congestion • Mucus

Alcohol Free

Tussin CF

Natural Stawberry Flavor

4 FL OZ (118 mL)

Inactive Ingredients

citric acid, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol

Stop Use and Ask A Doctor If

you get 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.

Ask A Doctor Before Use If You Have

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

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 43683-2 (43683-2)

mL=mililiter;tsp=teaspoonful

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active ingredients (in each 5 mL = 1 teaspoon)	Purposes
Dextromethorphan HBr, USP 10 mg	Cough Suppressant
Guaifenesin, USP 100 mg	Expectorant
Phenylephrine HCl, USP 5 mg	Nasal Decongestant

Questions

1-800-858-3889

Directions

do not take more than 6 doses in any 24-hour period
this adult product is not intended for children under 12 years old
mL=mililiter;tsp=teaspoonful

Age (years)	Dose
12 and over	2 teaspoons (10 mL) every 4 hours
Under 12	do not use

Do Not Use (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.

Other Information (Other information)

each teaspoon (5 mL) contains: sodium 2 mg
store at 15-30°C (59-86°F)
measure only with dosage cup provided

Principal Display

Triple Action Voltee Para Esponol

TRUSTED SINCE 1978

New Look

Adult Formula

Bactimicina

Ages 12+ Years

Multi-Symptom • Liquid

Cough & Cold

Dextromethorphan HBr (Cough Suppresant)

Guaifenesin (Expectorant)

Phenylephrine HCl (Nasal Decongestant)

Non-Drowsy

Cough • Stuffy Nose

Chest Congestion • Mucus

Alcohol Free

Tussin CF

Natural Stawberry Flavor

4 FL OZ (118 mL)

Inactive Ingredients (Inactive ingredients)

citric acid, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you get 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Advanced Ingredient Data

[{"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "43683-2": "mL=mililiter;tsp=teaspoonful", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product do not use more than directed", "50568-5": "Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each 5 mL = 1 teaspoon) Purposes Dextromethorphan HBr, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Phenylephrine HCl, USP 5 mg Nasal Decongestant", "Questions": "1-800-858-3889", "Directions": "do not take more than 6 doses in any 24-hour period this adult product is not intended for children under 12 years old mL=mililiter;tsp=teaspoonful Age (years) Dose 12 and over 2 teaspoons (10 mL) every 4 hours Under 12 do not use", "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.", "Other information": "each teaspoon (5 mL) contains: sodium 2 mg store at 15-30°C (59-86°F) measure only with dosage cup provided", "Principal Display": "Triple Action Voltee Para Esponol TRUSTED SINCE 1978 New Look Adult Formula Bactimicina Ages 12+ Years Multi-Symptom • Liquid Cough & Cold Dextromethorphan HBr (Cough Suppresant) Guaifenesin (Expectorant) Phenylephrine HCl (Nasal Decongestant) Non-Drowsy Cough • Stuffy Nose Chest Congestion • Mucus Alcohol Free Tussin CF Natural Stawberry Flavor 4 FL OZ (118 mL)", "Inactive ingredients": "citric acid, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol", "Stop use and ask a doctor if": "you get 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.", "Ask a doctor before use if you have": "heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:08.150603 · Updated: 2026-03-14T23:12:17.704012