Label: NINJACOF COTTON CANDY FLAVOR- 16 OZ- antitussive and antihistamine liquid
- NDC Code(s): 79804-032-16
- Packager: Eagle Labs Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Updated January 20, 2022
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- Active Ingredient
- Cold and Cough- Anitussive and Antihistamine
Do not exceed recommended dosage.
DO NOT USE IF PRINTED SAFETY SEAL IS MISSING OR BROKEN.
Do not use this product
If you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain
drugs for depression, psychiatric, or emotional conditions or Parkinsons disease),
or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription
drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
A cough that lasts or is chronic such as occurs with smoking, asthma, or
A cough that occurs with too much phlegm (mucus)
Ask doctor or pharmacist before use if you are
Taking sedatives or tranquilizers
If you have a breathing problem such as emphysema or chronic bronchitis
If you have glaucoma
If you have difficulty in urination due to enlargement of the prostate gland
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
Do not exceed recommended dosage.
In case of overdose, get medical help or contact a Poison
Control Center right away
Adults and children
12 years of age
and over: 2 teaspoonfuls (10mL) every 6 to 8
hours not to exceed 8 teaspoons in
Children 6 to under
12 years of age:1 teaspoonfuls (5ml) every 6 to 8
hours not to exceed 4 teaspoons in
6 years of age: Consult a doctor.
- Inactive Ingredients
- Questions? Comments?
- Ninjacof Cotton Candy Flavor 16 oz
INGREDIENTS AND APPEARANCE
NINJACOF COTTON CANDY FLAVOR- 16 OZ
antitussive and antihistamine liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79804-032 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE 12.5 mg in 5 mL PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 12.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor COTTON CANDY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79804-032-16 473 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package 12/17/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/17/2021 Labeler - Eagle Labs Inc. (118496872) Establishment Name Address ID/FEI Business Operations Eagle Labs Inc. 118496872 manufacture(79804-032) , label(79804-032) , pack(79804-032)