Tenalif

Tenalif
SPL v5
SPL
SPL Set ID 9a246099-72b5-2efc-e053-2a95a90aafbc
Route
ORAL
Published
Effective Date 2022-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 781 Shape: oval Color: yellow Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-18

Description

Drug facts


Medication Information

Warnings and Precautions

Description

Drug facts

Uses

helps looseen 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 51727-6

D&C yellow No. 10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

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 softgels 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 humiditydity

Questions Or Comments?

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

Principal Display Panel

NDC 69729-783-02

Tenalif® - Adults

Tesaperlas

Expectorante & Supresor de la Tos

Expectorant & Cough Suppressant

Controls cough

Controla la tos

Thins & loosens mucus

Adelgaza y expulsa las flemas

SOFTGELS

Dextromethorphan HBr 20 mg / Guaifenesin 400 mg

20 Softgels Box

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.

If Pregnant Or Breast Feeding

ask a health professional before use

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 smooking, asthma, chronic bronchitis, or emphysema


Structured Label Content

Uses

helps looseen phlegm (mucus)

helps thin bronchial secretions to make coughs more productive

Warnings and Precautions (34071-1)

Section 42229-5 (42229-5)

Drug facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

D&C yellow No. 10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

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 softgels 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 (Other information)

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

Avoid excessive heat and humiditydity

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 69729-783-02

Tenalif® - Adults

Tesaperlas

Expectorante & Supresor de la Tos

Expectorant & Cough Suppressant

Controls cough

Controla la tos

Thins & loosens mucus

Adelgaza y expulsa las flemas

SOFTGELS

Dextromethorphan HBr 20 mg / Guaifenesin 400 mg

20 Softgels Box

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.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use

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 smooking, asthma, chronic bronchitis, or emphysema


Advanced Ingredient Data


Raw Label Data

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