Abanatuss ped solution

Drug facts

Active ingredients (in each 5ml tsp)

Chlophedianol HCL, 25 mg

Dexchlorpheniramine Maleate, 2 mg

Pseudoephedrine HCL, 60 mg

Purpose

Cough Suppressant

Antihistamine

Nasal Decongestant

Otc - keep out of reach of children section

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Indications & usage section

Usestemporarily 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 section

Warnings Do not usein 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 hasdiabetes 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 ifyour child is taking sedatives or tranquilizers

When using this product do not exceed recommended dosagemay 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 ifnervousness, 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 section

Directionsdo not take more than 4 doses in any 24-hour period.

Adults and Children 12 years of age and over 5 mL (1 tsp), every 6 hours
Children 6 to under 12 years of age 2.5 mL (1/2 tsp), every 6 hours
Children under 6 years of age Consult physician

Inactive ingredient section

Inactive Ingredientscitric acid, flavors, propylene glycol, sodium benzoate, sorbitol, sucralose and water

Storage and handling section

Other informationStore at controlled room temperature 15-30C (59-86F) protect from freezing protect from light Avoid excessive heat or humidity. TAMPER EVIDENT: Do not use this product if breakaway band on cap is broken or missing.

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*

SUGAR FREE

DYE FREE

ALCOHOL FREE

GLUTEN FREE

TROPICAL FRUIT FLAVOR

Ingredients and appearance - Product information

Abanatuss ped solution- Chlophedianol hydrochloride, dexchlorpheniramine maleate, pseudoephedrine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 52083-675
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Chlophedianol hydrochloride ( UNII: 69QQ58998Y)( Chlophedianol - UNII: 42C50P12AP ) 25 mgin 5 mL
Dexchlorpheniramine maleate ( UNII: B10YD955QW)( Dexchlorpheniramine - UNII: 3Q9Q0B929N ) 2 mgin 5 mL
Pseudoephedrine hydrochloride ( UNII: 6V9V2RYJ8N)( Pseudoephedrine - UNII: 7CUC9DDI9F ) 60 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Citric acid monohydrate ( UNII: 2968PHW8QP)
Propylene glycol ( UNII: 6DC9Q167V3)
Sodium benzoate ( UNII: OJ245FE5EU)
Sorbitol ( UNII: 506T60A25R)
Sucralose ( UNII: 96K6UQ3ZD4)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Flavor FRUIT (Tropical fruit)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - KRAMER NOVIS( 090158395)

Packaging