TOPCARE COLD MAX- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl solution
Topco Associates LLC
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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Topco Associates LLC. Cold Max Drug Facts
Active ingredients (in each 15 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Uses
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- temporarily relieves these common 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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- nasal congestion
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- runny nose and sneezing
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- cough
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- sinus congestion and pressure
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- helps clear nasal passages
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- relieves cough to help you sleep
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- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
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
Ask a doctor before use if you have
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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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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- do not exceed recommended dose
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- excitability may occur, especially in children
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- marked drowsiness may occur
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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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- nervousness, dizziness, or sleeplessness occur
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- pain, nasal congestion 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.
Keep out of reach of children.
Overdose warning: 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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- mL = milliliter
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- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
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adults and children 12 years and over |
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children under 12 years |
ask a doctor |
Other information
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- each 15 mL contains: sodium 5 mg
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- store at 20°-25°C (68°-77°F). Do not refrigerate.
Inactive ingredients
anhydrous citric acid, FD&C blue no. 1, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
Package/Label Principal Display Panel
COMPARE TO TYLENOL® COLD MAX ACTIVE INGREDIENTS
COOL ICE®
NIGHTTIME
Cold Max
PAIN RELIEVER/FEVER REDUCER ● ACETAMINOPHEN
COUGH SUPPRESSANT ● DEXTROMETHORPHAN HBr
ANTIHISTAMINE ● DOXYLAMINE SUCCINATE
NASAL DECONGESTANT ● PHENYLEPHRINE HCl
OUR PHARMACISTS RECOMMEND
Headache ● Fever ● Sore Throat
Nasal Congestion ● Cough
Runny Nose
8 FL OZ (240 mL)
For Adults
| TOPCARE COLD MAX
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl solution |
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| Labeler - Topco Associates LLC (006935977) |