COLD AND COUGH NIGHTTIME COOL BLAST- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
QUALITY CHOICE (Chain Drug Marketing Association)
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Drug Facts
Active ingredients (in each 30 mL, 2 tablespoons)
Acetaminophen 1000 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses (8 tablespoons or 120 mL) in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
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.
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have
- glaucoma
- liver disease
- cough that occurs with too much phlegm (mucus)
- breathing problems such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking
- sedatives or tranquilizers
- the blood thinning drug warfarin
When using this product
- do not exceed recommended dose (see overdose warning)
- 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
Stop use and ask a doctor if
- redness or swelling is present
- new symptoms occur
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see Overdose warning)
- use dosage cup provided. Do not use any other dosing device.
- tbsp - tablespoon, mL = milliliter
| age | dose |
| adults and children 12 years and over |
|
| children under 12 years |
|
Inactive ingredients
acesulfame potassium, carboxymethylcellulose sodium, citric acid, FD&C blue 1, flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose
Principal Display Panel
*Compare to the active ingredients in Tylenol® Cold & Cough Night Time
Nighttime Cold & Cough
Cool Blast
Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Doxylamine Succinate - Antihistamine
For Ages 12 & Over
Distributed by C.D.M.A., Inc.
43157 W. Nine Mile
Novi, MI 48379-0995
www.qualitychoice.com
Questions: 248-449-9300
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.
*This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol® Cold & Cough Nighttime.
PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org
| COLD AND COUGH
NIGHTTIME COOL BLAST
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid |
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| Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774) |