TOPCARE COUGH COLD AND FLU SIMPLE RELIEF- choline salicylate, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

TOPCARE COUGH COLD AND FLU SIMPLE RELIEF by

Drug Labeling and Warnings

TOPCARE COUGH COLD AND FLU SIMPLE RELIEF by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

TOPCARE COUGH COLD & FLU SIMPLE RELIEF

(choline salicylate, dextromethorphan hbr, guaifenesin, phenylephrine hcl), solution

Topco Associates LLC

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Topco Associates LLC. Cough Cold & Flu Simple Relief Drug Facts

Drug Facts

Active ingredients (in each 30 mL)

Choline Salicylate (NSAID)* 870 mg

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

*nonsteroidal anti-inflammatory drug

Uses

temporarily relieves these common cold and flu symptoms:

▪ cough

▪ nasal congestion

▪ minor aches and pains

▪ sore throat

▪ headache

▪ temporarily reduces fever

▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Reye's syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert

Salicylates (NSAIDs) may cause a severe allergic reaction which may include:

▪ hives

▪ rash

▪ shock

▪ skin reddening

▪ facial swelling

▪ asthma (wheezing)

Stomach bleeding warnings

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

▪ are age 60 or older

▪ have had stomach ulcers or bleeding problems

▪ take a blood thinning (anticoagulant) or steroid drug

▪ take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

▪ have 3 or more alcoholic drinks every day while using this product

▪ take more or for a longer time than directed

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

▪ if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/fever reducer.

▪ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or 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.

▪ in children under 12 years of age

Ask a doctor before use if

▪ stomach bleeding warning applies to you

▪ you have a history of stomach problems, such as heartburn or if you have ulcers or bleeding problems

▪ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, diabetes or thyroid disease

▪ you have a cough with excessive phlegm (mucus)

▪ you have difficulty in urination due to enlargement of the prostate gland

▪ you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

• you have a chronic pulmonary disease or shortness of breath

▪ you have asthma

▪ you are taking a diuretic

 

Ask a doctor or pharmacist before use if you are

▪ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout, or arthritis.

▪ under a doctor’s care for any serious condition

When using this product,

do not use more than directed

Stop use and ask a doctor if

▪ an allergic reaction occurs. Seek medical help right away.

▪ pain, cough, 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

▪ ringing in the ears or a loss of hearing occurs

▪ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

▪ nervousness, dizziness, or sleeplessness occurs

▪ you experience any of the following signs of stomach bleeding:

▪ feel faint

▪ vomit blood

▪ have bloody or black stools

▪ have stomach pain that does not get better

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use salicylates (NSAIDs) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not exceed recommended dosage.
  
• do not take more than 6 doses in any 24-hour period.
  
• measure only with dosing cup provided
  
• do not use dosing cup with other products
  
• dose as follows or as directed by a doctor
  
• mL = milliliters

• age: dose
• adults and children 12 years of age and over: 30 mL every 4 hours
• children under 12 years of age: do not use

Other information

▪ each 30mL contains: Sodium 16mg

▪ store at room temperature 68°- 86°F (20°- 30°C)

Inactive ingredients

citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

Questions or comments?

Call 1-888-423-0139

PRINCIPAL DISPLAY PANEL

NDC: 36800-777-08
TopCare
health
Cough, Cold
& Flu
SIMPLE RELIEF
8 FL OZ (237mL)

INGREDIENTS AND APPEARANCE

TOPCARE COUGH COLD AND FLU SIMPLE RELIEF 
choline salicylate, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-777
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ)	CHOLINE SALICYLATE	870 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 30 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-777-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/06/2016

Labeler - TOPCO ASSOCIATES LLC (006935977)