Adult Long Lasting Cough Relief

Adult Long Lasting Cough Relief
SPL v4
SPL
SPL Set ID 8ef37bfa-ae80-4575-8394-f97ae95b4a01
Route
ORAL
Published
Effective Date 2024-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol 400 Povidone Propylene Glycol Sorbitan Water Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: SD29 Shape: capsule Color: pink Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-08

Description

Drug Facts

Purpose

Cough suppressant


Medication Information

Purpose

Cough suppressant

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor ifcough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50569-3

Ask a doctor before use if you have

• a cough that occurs with too much phlegm (mucus)

• a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Section 50570-1

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.

Section 53414-9

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

uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Directions

do not take more than 8 softgels in any 24-hour period

this adult product is not intended for use in children under 12 years of age

adults and children 12 years and over take 2 softgels every 6 to 8 hours, as needed
children under 12 years do not use

Other Information

• store at controlled room temperature 20-25ºC (68-77ºF)

• avoid excessive heat above 40°C (104°F)

• protect from light

Inactive Ingredients

FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow 06, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitan

Questions Or Comments?

1-800-373-6981 (toll-free)

Principal Display Panel

ValuRx

Compare to the active ingredient in Robitussin® Long-Acting Coughgels®†

Up to 8 Hr. Relief

Adult Long-Lasting

Cough Relief

Dextromethorphan HBr

(Cough Suppressant)

Active Ingredient (in Each Softgel)

Dextromethorphan HBr, USP 15 mg


Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

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 (1-800-222-1222).

Section 50566-9 (50566-9)

Stop use and ask a doctor ifcough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

• a cough that occurs with too much phlegm (mucus)

• a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

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

Purpose

Cough suppressant

uses (Uses)

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Directions

do not take more than 8 softgels in any 24-hour period

this adult product is not intended for use in children under 12 years of age

adults and children 12 years and over take 2 softgels every 6 to 8 hours, as needed
children under 12 years do not use

Other Information (Other information)

• store at controlled room temperature 20-25ºC (68-77ºF)

• avoid excessive heat above 40°C (104°F)

• protect from light

Inactive Ingredients (Inactive ingredients)

FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow 06, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitan

Questions Or Comments? (Questions or comments?)

1-800-373-6981 (toll-free)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ValuRx

Compare to the active ingredient in Robitussin® Long-Acting Coughgels®†

Up to 8 Hr. Relief

Adult Long-Lasting

Cough Relief

Dextromethorphan HBr

(Cough Suppressant)

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Dextromethorphan HBr, USP 15 mg


Advanced Ingredient Data


Raw Label Data

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