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Drug Facts
Adult Cough Plus Chest Congestion Dm Solution
FDA Label NDC 0363-7754
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Adult Cough Plus Chest Congestion Dm (NDC 0363-7754). 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, indications & usage, warnings, otc - do not use, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, 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 20 mg | Cough suppressant |
Guaifenesin, USP 400 mg | Expectorant |
Indications & Usage
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
Warnings
Warnings
Otc - 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.
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
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.
Dosage & Administration
Directions
▪ do not take more than 6 doses in any 24-hour period▪ measure only with dosing cup provided▪ keep dosing cup with product▪ ml = milliliter▪ 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 4 hours |
children under 12 years | do not use |
Storage And Handling
Other information
▪ each 20 ml contains: sodium 10 mg▪ store at room temperature. Do not refrigerate.
Inactive Ingredient
Inactive ingredients
citric acid, carboxymethylcellulose sodium, edetate disodium, glycerin, honey, natural & artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum, zinc gluconate
Otc - Questions
Questions or comments?
1-866-467-2748
Principal Display Panel - 118 Ml Bottle Label
Compare to active ingredients in Robitussin® Honey Cough + Chest Congestion DM MAX*
NDC 0363-7754-04
Adult
Cough + Chest
Congestion DM
With Honey
Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)
Maximum Strength
DM MAX
- Controls Cough
- Relieves Chest Congestion
- Thins & Loosens Mucus
- Gluten Free
- No Artificial Colors
- No Added Alcohol
Taste the Real Honey
For Ages 12 & Over
4 FL OZ (118 ml)
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Adult Robitussin® Honey Cough + Chest Congestion DM MAX.
TAMPER EVIDENT: DON NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING
IMPORTANT: Keep this carton for future reference for full labelling.
Distributed by:
Wag Adult Cough+ Chest Congestion Dm With Honey (Robitussin 01)
* Please review the disclaimer below.
