TOPCARE PAIN RELIEVER SIMPLE RELIEF- caffeine, choline salicylate solution 
TOPCO ASSOCIATES LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

TOPCARE PAIN RELIEVER SIMPLE RELIEF

TopCare Pain Reliever Simple Relief 

(choline salicylate & caffeine), solution

Topco Associates LLC

--

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

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:

Stomach bleeding warning

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

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

Other Information

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)

PRINCIPAL DISPLAY PANEL
NDC 36800-518-34
Pain
Simple Relief
8 OZ FL (237mL)

PRINCIPAL DISPLAY PANEL
NDC 36800-518-34
Pain
Simple Relief
8 OZ FL (237mL)

PRINCIPAL DISPLAY PANEL
NDC 36800-518-34
Pain
Simple Relief
8 OZ FL (237mL)

TOPCARE PAIN RELIEVER SIMPLE RELIEF 
caffeine, choline salicylate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-518
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg  in 30 mL
CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ) CHOLINE SALICYLATE870 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-518-34237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/06/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34309/06/2016
Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 6/2016
Document Id: 7434d73f-807b-4fe2-9796-db2ec9a7d4ac
Set id: fee15739-13ef-4ff3-b989-680c732af024
Version: 1
Effective Time: 20160628
 
TOPCO ASSOCIATES LLC