TOPCARE PAIN RELIEVER SIMPLE RELIEF- caffeine, choline salicylate solution

TOPCARE PAIN RELIEVER SIMPLE RELIEF by

Drug Labeling and Warnings

TOPCARE PAIN RELIEVER 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 Pain Reliever Simple Relief ™ 

(choline salicylate & caffeine), solution

Topco Associates LLC

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Topco Associates LLC. Pain Reliever Drug Facts

Drug Facts

Active Ingredients per 30mL

Caffeine 65 mg

Choline Salicylate (NSAID)* 870 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever Aid

Pain Reliever / Fever Reducer (NSAID)

Uses

• temporarily relieves minor aches and pains due to:
  ○ headache
  ○ minor arthritis pain
  ○ muscle aches
  ○ menstrual cramps
  ○ backache
  
• temporarily reduces fever

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
  
• skin reddening
  
• rash
  
• facial swelling
  
• shock
  
• asthma (wheezing)

Stomach bleeding warning

 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 blood thinning (anticoagulant) or steroid drug
  
• take other drugs containing prescription or nonprescription 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

Do not use

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

Ask a doctor before use if

• stomach bleeding warning applies to you
  
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  
• you have a history of stomach problems such as heartburn, upset stomach, stomach pain, or ulcers
  
• you are taking a diuretic
  
• you have asthma

Ask a doctor or pharmacist before use if

• under a doctor's care for any serious condition
  
• taking a prescription drug for anticoagulation (thinning of the blood), diabetes, gout, or arthritis.

When using this product

• limit the use of caffeine containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat
  
•  the recommended dose of this product contains about as much caffeine as a cup of coffee

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
  
• 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
  
• pain gets worse or lasts more than 7 days
  
• fever gets worse or lasts more than 3 days
  
• ringing in the ears or loss of hearing occurs
  
• redness or swelling is present
  
• new symptoms occur
  
• symptoms do not improve
  
• ringing in the ears or loss of hearing occurs

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

• adults and children 12 years of age and over: take 30 mL every 6 hours, while symptoms persist
  
• do not exceed 4 doses in 24 hours unless directed by a doctor
  
• children under 12 years of age: ask a doctor
  
• use enclosed dose cup

Other Information

• each 30mL contains: Sodium 19 mg
  
• tamper evident: Do not use if foil seal under cap is broken or missing.
  
• read all product information before using
  
• store at 68° to 86°F (20° to 30°C)
  
• avoid excessive heat and humidity

Inactive Ingredients

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

Questions or comments?

Call 1-888-423-0139

PRINCIPAL DISPLAY PANEL

NDC: 36800-518-34
Pain
Simple Relief
8 OZ FL (237mL)

INGREDIENTS AND APPEARANCE

TOPCARE PAIN RELIEVER SIMPLE RELIEF 
caffeine, choline salicylate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-518
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg  in 30 mL
CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ)	CHOLINE SALICYLATE	870 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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: 36800-518-34	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 NOT FINAL	part343	09/06/2016

Labeler - TOPCO ASSOCIATES LLC (006935977)