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Amazon Solution
FDA Label NDC 72288-587
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amazon.com Services Llc for the product Amazon (NDC 72288-587). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 20 ml) | Purposes |
|---|---|
Dextromethorphan HBr, USP 30 mg | Cough suppressant |
Doxylamine Succinate, USP 12.5 mg | Antihistamine |
Uses
▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold▪ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:▪ runny nose▪ sneezing▪ itchy, watery eyes▪ itching of the nose or throat
▪ controls the impulse to cough to help you sleep
Do Not Use
▪ to sedate a child or to make a child sleepy▪ 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
▪ trouble urinating due to an enlarged prostate gland▪ glaucoma▪ a cough that occurs with too much phlegm (mucus)▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
Otc - Ask Doctor/Pharmacist
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▪ alcohol, sedatives, and tranquilizers may increase drowsiness▪ be careful when driving a motor vehicle or operating machinery▪ excitability may occur, especially in children
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Directions
▪ measure only with dosing cup provided▪ keep dosing cup with product▪ mL = milliliter▪ do not take more than 4 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 | 20 ml every 6 hours |
children under 12 years | do not use |
Other Information
▪ each 20 ml contains: sodium 6 mg▪ store at room temperature.
Inactive Ingredients
anhydrous citric acid, FD&C Red #40, flavor, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
Compare to the active ingredients in Adult Robitussin® Maximum Strength Nighttime Cough DM *
NDC 72288-587-04
MAXIMUM STRENGTH
Adult Nighttime Cough DM
Dextromethorphan HBr (Cough Suppressant)
Doxylamine Succinate (Antihistamine)
- Controls Cough
- Relieves Runny Nose & Sneezing
For Ages 12 & Over
4 FL OZ (118 mL)
Distributed by:
IMPORTANT: Keep this carton for future reference for full labelling.
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.
*This product is not manufactured or distributed by Haleon US Holding LLC, owner of the registered trademark Adult Robitussin® Maximum Strength Nighttime Cough DM.
Amazon Maximum Strength Adult Nighttime Cough Dm 118ml (Robitussin 01)
* Please review the disclaimer below.
