Adult tussin Peak Cold Multi-Symptom Cold

Manufacturer
Aurohealth LLC
Effective date
2019-11-28
Label type
Human OTC Drug Label
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:56:32

Label at a glance#

ProductAdult tussin Peak Cold Multi-Symptom Cold
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure15 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

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

Storage and handling

each 10 mL contains: sodium 6 mg store at 20-25°C (68-77°F). Do not refrigerate see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg
Phenylephrine HCl, USP 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

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
  • 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

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 do not use more than directed

OTC - WHEN USING SECTION

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.

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 right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION


  • do not take more than 6 doses (12 tsp) in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age

Age
Dose
adults and children
12 years and over
10 mL
every 4 hours
children under 12 years
do not use

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL contains: sodium 6 mg
  • store at 20-25°C (68-77°F). Do not refrigerate
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C Red No. 40 powder, glycerin, menthol, noncrystallizing sorbital solution, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose.

Questions or Comments

OTC - QUESTIONS SECTION

1-855-274-4122

Distributed by:
Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -8 FL OZ (237 mL Container Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-514-20
Primary Health

Compare to Adult Robitussin®
Peak Cold Multi-Symptom Cold
Active ingredients*

ADULT
Tussin
PEAK COLD
Multi-Symptom Cold

Each 10 mL dose of oral solution contains:
20 mg - Dextromethorphan HBr, USP (Cough Suppressant)
200 mg - Guaifenesin, USP (Expectorant)
10 mg- Phenylephrine HCl, USP (Nasal Decongestant)

Relieves:

  • Cough
  • Nasal Congestion
  • Mucus 
  • For Ages 12 & Over

Raspberry Flavor
Non-Drowsy                                       
8 FL OZ(237 mL)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -8 FL OZ (237 mL Container Label)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -8 FL OZ (237 mL Container Label)



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -8 FL OZ (237 mL Container Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-514-20
Primary Health

Compare to Adult Robitussin®
Peak Cold Multi-Symptom Cold
Active ingredients*

ADULT
Tussin
PEAK COLD
Multi-Symptom Cold

Each 10 mL dose of oral solution contains:
20 mg - Dextromethorphan HBr, USP (Cough Suppressant)
200 mg - Guaifenesin, USP (Expectorant)
10 mg- Phenylephrine HCl, USP (Nasal Decongestant)

Relieves:

  • Cough
  • Nasal Congestion
  • Mucus
  • For Ages 12 & Over

Rasberry Flavor
Non-Drowsy                                       
8 FL OZ(237 mL)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -8 FL OZ (237 mL Container Carton Label)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -8 FL OZ (237 mL Container Carton Label)


Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-51458602-514-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

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
2a914263-c372-4f57-8ad2-d910f481289f9b25af98-d826-4a45-80b2-ae447b1fe2ed2020-11-27WarningsExact identifier
spl set id: 9b25af98-d826-4a45-80b2-ae447b1fe2ed

Reported adverse events (FAERS/openFDA)#

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