Label: ABANATUSS PED- chlophedianol hydrochloride, dexchlorpheniramine maleate, pseudoephedrine hydrochloride solution
- NDC Code(s): 52083-675-16
- Packager: KRAMER NOVIS
- 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 November 13, 2019
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- Drug Facts
- Active Ingredients (in each 5mL tsp)
- KEEP OUT OF REACH OF CHILDREN
INDICATIONS & USAGE
Uses • temporarily calms cough due to minor throat and bronchial irritation as may occur with the common cold • calms the cough control center and relieves coughing • Non narcotic cough suppressant for the temporary relief of cough • controls cough impulse without narcotics • temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other respiratory allergies • temporarily relieves nasal congestion due to the common cold • helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure.
Warnings • Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains as MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if your child has • diabetes • heart disease • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema • glaucoma • breathing problem such as emphysema or chronic bronchitis.
Ask a doctor or pharmacist before use if your child is taking sedatives or tranquilizers
When using this product do not exceed recommended dosage • may cause excitability especially in children • may cause marked drowsiness, alcohol, sedatives and tranquilizers may increase the drowsiness effect • avoid alcoholic beverages while taking this product • use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not get better within 7 days or are accompanied by fever • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
SPL UNCLASSIFIED SECTION
Manufactured in the USA for Kramer Novis, San Juan, PR 00917. Tel: (787) 767-2072 / www.kramernovis.com
* Panatuss® PED is a registered trademark of Seyer Pharmatec. This product is not manufactured, distributed or marketed by Seyer Pharmatec.
Contains the same active ingredients as Panatuss® PED*
TROPICAL FRUIT FLAVOR
INGREDIENTS AND APPEARANCE
chlophedianol hydrochloride, dexchlorpheniramine maleate, pseudoephedrine hydrochloride solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-675 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE 25 mg in 5 mL DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE 2 mg in 5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor FRUIT (Tropical fruit) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-675-16 474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/01/2015 Labeler - KRAMER NOVIS (090158395) Registrant - KRAMER NOVIS (090158395)