COLD AND COUGH- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid
H E B
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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Active ingredients (in each 15 mL = 1 tablespoon)
Acetaminophen 500 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Purpose
Pain reliever
Cough suppressant
Antihistamine
Uses
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- temporarily relieves the following cold/flu symptoms:
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- minor aches and pains
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- headache
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- sore throat
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- runny nose and sneezing
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- cough
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoons (3,000 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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.
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- if you have ever had an allergic reaction to this product or any of its ingredients
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- to make a child sleepy
Ask a doctor before use if you have
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- liver disease
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- glaucoma
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- trouble urinating due to an enlarged prostate gland
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- a breathing problem such as emphysema or chronic bronchitis
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- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
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- taking the blood thinning drug warfarin
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- taking sedatives or tranquilizers
When using this product
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- excitability may occur, especially in children
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- may cause marked drowsiness
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- alcohol, sedatives and tranquilizers may increase drowsiness
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- avoid alcoholic drinks
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- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
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- pain or cough gets worse or lasts more than 7 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- cough comes back or occurs with rash or headache that lasts.
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.
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 right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
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- do not take more than directed (see overdose warning)
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- use only enclosed dosing cup designed for this product. Do not use any other dosing device.
adults & children 12 years & over
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- take 30 mL (2 TBSP) in dose cup provided every 6 hours
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- do not take more than 6 tablespoons in 24 hours
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children under 12 years
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- ask a doctor
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Other information
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- each tablespoon contains: potassium 25 mg and sodium 8 mg
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- store at 20-25°C (68-77°F). Do not refrigerate.
Inactive ingredients
acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue #1, flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose
Questions or comments?
1-800-719-9260
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Compare to the active ingredients of Tylenol® Cold & Cough Nighttime Cool Burst® Liquid
COLD & COUGH
Night Time
Cool Ice®
Acetaminophen – Dextromethorphan HBr – Doxylamine Succinate
Pain Reliever – Cough Suppressant – Antihistamine
Sore Throat
Body Aches
Headache
Coughing
Runny Nose
Instant Cooling Sensation
GLUTEN FREE
8 FL OZ (237 mL) Liquid