Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)
Mondelez Global LLC
ORAL
OTC DRUG
OTC monograph not final
HALLS BREEZERS SUGAR FREE COOL BERRY- PECTIN LOZENGE MONDELEZ GLOBAL 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._ ---------- HALLS SUGAR FREE COOL BERRY ACTIVE INGREDIENT (per drop) Pectin 7 mg PURPOSEUSES Les hele dokumentetWARNINGS < SORE THROAT WARNING: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.> STOP USE AND ASK A DOCTOR IF sore mouth does not improve in 7 days irritation, pain, or redness persists or worsens KEEP OUT OF REACH OF CHILDREN DIRECTIONS adults and children 5 years and over: dissolve 1 or 2 drops (one at a time) slowly in the mouth. Repeat as needed. children under 5 years: ask a doctor OTHER INFORMATION phenylketonurics: contains phenylalanine 2 mg per drop excessive consumption may have a laxative effect 10 calories per drop CONTAINS: SOY. INACTIVE INGREDIENTS acesulfame potassium, aspartame, citric acid, FDC blue 2, FDC red 40, flavors, isomalt, malic acid, maltitol syrup, potassium citrate, soy lecithin, titanium dioxide, water QUESTIONS OTC PRINCIPAL DISPLAY PANEL HALLS BREEZERS SUGAR FREE COOL BERRY pectin lozenge PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:12546-720 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 7 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ASPARTAME (UNII: Z0H242BBR1) Mondelez Global LLC ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 2 (UNII: L06K8