Histiacil Cough

Histiacil Cough
SPL v4
SPL
SPL Set ID 7ca99ad2-5127-4a33-bfc6-7c2f596a2b25
Route
ORAL
Published
Effective Date 2022-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
D&c Yellow No. 10 Gelatin, Unspecified Glycerin Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 781 Shape: oval Color: yellow Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

helps loosen phlegm (mucus)

helps thin bronchial secretions to make coughs more productive

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children

Section 53414-9

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

Section 55105-1
ACTIVE INGREDIENTS (in each softgel) PURPOSE
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Directions

Do not take more than directed - See Overdose warning

Do not use for more than 7 days.

Do not take more than 6 doses in 24 hours

Adults and children

12 years of age & over
Take 1 softgel every 4 hours with a full glass of water while symptoms persist
Children

under 12 years of age
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.

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information

Store at room temperature between 20-25°C (68-77°F)

Avoid excessive heat and humidity

Inactive Ingredients

FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

Questions Or Comments?

Call: (619) 600-5632 (Mon-Fri 9am-5pm EST)

Stop Use and Ask A Doctor If

cough lasts for more than 7 days, recurs, or is accompained by fever, rash, or persistent headache. These could be signs of a serious condition

Ask A Doctor Before Use If You Have

cough that occurs with too much phlegm (mucus)

cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Principal Display Panel 20 Softgel Blister Pack Box

NDC 69729-000-00

Histiacil NF

Dextromethorphan HBr

Guaifenesin

Cough

Expectorant & Cough Supressant

  • Controls cough
  • Thins & loosens mucus
  • Easy to swallow

20 Softgels Box


Structured Label Content

Uses

helps loosen phlegm (mucus)

helps thin bronchial secretions to make coughs more productive

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children

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 softgel) PURPOSE
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Directions

Do not take more than directed - See Overdose warning

Do not use for more than 7 days.

Do not take more than 6 doses in 24 hours

Adults and children

12 years of age & over
Take 1 softgel every 4 hours with a full glass of water while symptoms persist
Children

under 12 years of age
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.

Overdose Warning (Overdose warning)

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information

Store at room temperature between 20-25°C (68-77°F)

Avoid excessive heat and humidity

Inactive Ingredients

FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

Questions Or Comments? (Questions or comments?)

Call: (619) 600-5632 (Mon-Fri 9am-5pm EST)

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

cough lasts for more than 7 days, recurs, or is accompained 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)

cough that occurs with too much phlegm (mucus)

cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Principal Display Panel 20 Softgel Blister Pack Box (PRINCIPAL DISPLAY PANEL - 20 Softgel Blister Pack Box)

NDC 69729-000-00

Histiacil NF

Dextromethorphan HBr

Guaifenesin

Cough

Expectorant & Cough Supressant

  • Controls cough
  • Thins & loosens mucus
  • Easy to swallow

20 Softgels Box


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)