207b5fa1-8c19-9efc-665f-a3f8987d03e7 — v1

4 Views

Version

v1

Effective date

August 3, 2009

Original packager

Sections captured

17

Identifiers

Document ID
207b5fa1-8c19-9efc-665f-a3f8987d03e7
Set ID
207b5fa1-8c19-9efc-665f-a3f8987d03e7
Application numbers
Product NDCs
Package NDCs
Original packager NDCs

Names & Manufacturers

Brand names
Generic names
Manufacturer names
Product types

Substances & Pharmacology

Substance names
Routes
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

ACTIVE INGREDIENTS (IN EACH 5 ML TSP) Diphenhydramine HCl, USP 12.5 mg Guaifenesin, USP 200 mg
Ask Doctor (1)

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Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Ask Doctor Or Pharmacist (1)

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Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Do Not Use (1)

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Do not use to sedate a child or to make a child sleepy with any other product containing diphenhydramine, even one used on skin
Inactive Ingredient (1)

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INACTIVE INGREDIENTS anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
Indications And Usage (1)

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USES temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Keep Out Of Reach Of Children (1)

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Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
Package Label Principal Display Panel (1)

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PRODUCT PACKAGING The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available. Adult Robitussin Night Time Cough and Chest Congestion DIPHENHYDRAMINE HCl (Cough Suppressant) GUAIFENESIN (Expectorant) RELIEVES: Cough Chest Congestion/Mucus Maximum Strength for MUCUS RELIEF For Ages 12 & Over Alcohol-Free 4 FL OZ (118 mL) Robitussin Knows Choosing the right product is important. Robitussin has different products for adults and for children. GREEN Boxes – Ages 12 & Over RED Boxes – Ages Under 12 Use as directed. DOSAGE CUP INCLUDED Wyeth Consumer Healthcare Madison, NJ 07940 USA © 2009 Wyeth For most recent product information, visit www.robitussin.com Packaged with Tamper-Evident bottle cap. Do not use if breakable ring is separated or missing. Robitussin Night Time Cough and Chest Congestion Packaging
Pregnancy Or Breast Feeding (1)

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If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

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PURPOSES Cough suppressant Expectorant
Questions (1)

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QUESTIONS OR COMMENTS? call weekdays from 9 AM to 5 PM EST at 1-800-762-4675
Spl Product Data Elements (1)

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ROBITUSSIN NIGHT TIME COUGH AND CHEST CONGESTION diphenhydramine HCl, guaifenesin diphenhydramine hydrochloride diphenhydramine guaifenesin guaifenesin
Spl Unclassified Section (3)

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DRUG FACTS

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DIRECTIONS do not take more than 6 doses in any 24-hour period this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 teaspoons every 4 hours children under 12 years do not use

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OTHER INFORMATION each teaspoon contains : sodium 3 mg store at 20-25°C (68-77°F) dosage cup provided
Spl Unclassified Section Table (1)

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age dose
adults and children 12 years and over 2 teaspoons every 4 hours
children under 12 years do not use
Stop Use (1)

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Stop use and ask a doctor if 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.
Warnings (1)

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WARNINGS Do not use to sedate a child or to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or 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 taking sedatives or tranquilizers When using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if 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, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
When Using (1)

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When using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children