FDA Label for Topcare Cold And Sore Throat Lemon Flavor

Topcare Cold And Sore Throat Lemon Flavor

Active Ingredients (in each packet)                               Purpose

Acetaminophen 325 mg...................................Pain reliever/Fever reducer

Pheniramine maleate 20 mg................................................Antihistamine

Phenylephrine hydrochloride 10 mg.............................Nasal decongestant.

Otc - Purpose

Uses
- temporarily relieves these symptoms due to a cold:
    - minor aches and pains   - headache   - minor sore throat pain
    - nasal congestion   - temporarily reduces fever
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    - runny nose   - sneezing   - itchy nose and throat   - itchy, watery eyes.

Warnings

Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take   - more than 6 packets in 24 hours, which is the maximum daily amount   - with other drugs containing acetaminophen   - 3 or more alcoholic drinks every day while using this product.
Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Otc - Do Not Use

Do not use   - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
- 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 a MAOI, ask a doctor or pharmacist before taking this product.
- with any other product containing acetaminophen (see Overdose Warning).

Otc - Ask Doctor

Ask a doctor before use if you have
- liver disease   - heart disease   - high blood pressure   - thyroid disease   - diabetes   - glaucoma   - a breathing problem such as emphysema, asthma, or chronic bronchitis   - trouble urinating due to an enlarged prostate gland   - a sodium-restricted diet.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking
- sedatives or tranquilizers   - the blood thinning drug warfarin.

Indications & Usage

When using this product
- do not exceed recommended dosage
- avoid alcoholic drinks   - may cause drowsiness
- 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
- nervousness, dizziness, or sleeplessness occurs
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health care professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

Overdose Warning: Taking more than the recommended dose can cause serious health problems, including serious liver damage. In case of overdose, get medical help or contact a poison control center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration

Directions
- do not use more than directed (see Overdose Warning)
- take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor
- adults and children 12 years of age and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- children under 12 years of age: consult a doctor
- If using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Information For Patients

Other Information
- each packet contains: sodium 66 mg
- store at controlled room temperature 20-25C (68-77F).

Inactive Ingredient

Citric acid, D and C Yellow 10, Ethylcellulose, FD and C Red 40, Flavor, Microcrystalline cellulose, Povidone, Silicon Dioxide, Sodium Citrate, Starch, Sugar and Vitamin C.

Package Label.Principal Display Panel

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