TOPCARE COLD AND SORE THROAT LEMON FLAVOR- acetaminophen, pheniramine maleate, phenylephrine hcl granule, for solution

Topcare Cold and Sore Throat by

Drug Labeling and Warnings

Topcare Cold and Sore Throat by is a Otc medication manufactured, distributed, or labeled by TOPCARE (Topco Associates LLC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

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.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE COLD AND SORE THROAT  LEMON FLAVOR
acetaminophen, pheniramine maleate, phenylephrine hcl granule, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-802
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg
Pheniramine Maleate (UNII: NYW905655B) (Pheniramine - UNII:134FM9ZZ6M)	Pheniramine Maleate	20 mg
Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine hydrochloride	10 mg

Inactive Ingredients
Ingredient Name	Strength
Citric acid monohydrate (UNII: 2968PHW8QP)
Ethylcellulose (100 MPA.S) (UNII: 47MLB0F1MV)
Cellulose, microcrystalline (UNII: OP1R32D61U)
Povidone (UNII: FZ989GH94E)
Silicon dioxide (UNII: ETJ7Z6XBU4)
Sodium citrate (UNII: 1Q73Q2JULR)
Sucrose (UNII: C151H8M554)
Ascorbic acid (UNII: PQ6CK8PD0R)

Product Characteristics
Color	yellow (D and C Yellow 10) , red (FD and C Red 40)	Score
Shape		Size
Flavor	LEMON (Nature Lemon Flavor)	Imprint Code
Contains

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
OTC monograph final	part341	05/20/2014

Labeler - TOPCARE (Topco Associates LLC) (006935977)