Label: TOPCARE PAIN RELIEVER SIMPLE RELIEF- caffeine, choline salicylate solution
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-518-34 - Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 28, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients per 30mL
- Purpose
- Uses
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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
- hives
- Directions
- Other Information
- Inactive Ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOPCARE PAIN RELIEVER SIMPLE RELIEF
caffeine, choline salicylate solutionProduct 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)
