Topcare Cold and Sore Throat description, usages, side effects, indications, overdosage, supplying and lots more!

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Topcare Cold and Sore Throat

TOPCARE (Topco Associates LLC)

Topcare Cold and Sore Throat Lemon Flavor


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

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
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.

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).

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.

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

Uses

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.

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.

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

Keep out of reach of children.

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.

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.

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

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.

Topcare Cold and Sore Throat

Topcare Cold and Sore Throat

Acetaminophen, Pheniramine Maleate, Phenylephrine HCl GRANULE, FOR SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-802
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
PHENIRAMINE MALEATE Pheniramine 20 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
ETHYLCELLULOSE (100 MPA.S)
cellulose, microcrystalline
povidone
SILICON DIOXIDE
SODIUM CITRATE
SUCROSE
ASCORBIC ACID

Product Characteristics

Color
red (FD and C Red 40)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-802-06 6 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-05-20


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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