Country: United States
Language: English
Source: NLM (National Library of Medicine)
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)
Mondelez Global LLC
ORAL
OTC DRUG
OTC monograph not final
BREEZERS CREAMY STRAWBERRY- 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 BREEZERS CREAMY STRAWBERRY ACTIVE INGREDIENT <(per drop) Pectin 7 mg> PURPOSEUSES Read the complete documentWARNINGS 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 In case of overdose, get medical help or contact a Poison Control Center right away 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 <•15 calories • Contains: SOY.> INACTIVE INGREDIENTS QUESTIONS OTC PRINCIPAL DISPLAY PANEL BREEZERS CREAMY STRAWBERRY pectin lozenge PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:12546-352 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 .BETA.-CAROTENE (UNII: 01YAE03M7J) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Mondelez Global LLC FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZ