ABANATUSS PED

Manufacturer: KRAMER NOVIS
Effective date: 2019-11-13
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:01:22

Label at a glance#

ProductABANATUSS PED

Active ingredientCHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE

Label structure10 sections

Storage and handling

Other information • Store at controlled room temperature 15°-30°C (59°-86°F) • 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.

Contacts and useful links#

PhoneLabel contact(787) 767-2072

Websitewww.kramernovis.com

www.kramernovis.com

Label contents#

Full prescribing information#

Active Ingredients (in each 5mL tsp)

OTC - ACTIVE INGREDIENT SECTION

Chlophedianol HCL, 25 mg

Dexchlorpheniramine Maleate, 2 mg

Pseudoephedrine HCL, 60 mg

Purpose

OTC - PURPOSE SECTION

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

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 SECTION

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 SECTION

Directions • do 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 Ingredients citric acid, flavors, propylene glycol, sodium benzoate, sorbitol, sucralose and water

STORAGE AND HANDLING SECTION

Other information • Store at controlled room temperature 15°-30°C (59°-86°F) • 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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ped1

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1369972	Chlophedianol/Dexchlorpheniramine/Pseudoephedrine (Oral Liquid)	chlophedianol hydrochloride 5 MG/ML / dexchlorpheniramine maleate 0.4 MG/ML / pseudoephedrine hydrochloride 12 MG/ML Oral Solution	SCD Active

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-675-16	ML - Milliliter	52083-675	6d46f788-e135-4aa9-bc11-81df726ca9f9	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CHLOPHEDIANOL HYDROCHLORIDE	ACTIVE INGREDIENT	69QQ58998Y	1
DEXCHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	B10YD955QW	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	1
CHLOPHEDIANOL	ACTIVE MOIETY	42C50P12AP	1
DEXCHLORPHENIRAMINE	ACTIVE MOIETY	3Q9Q0B929N	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

ABANATUSS PED
CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE
CHLOPHEDIANOL HYDROCHLORIDE
CHLOPHEDIANOL
DEXCHLORPHENIRAMINE MALEATE
DEXCHLORPHENIRAMINE
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE
CITRIC ACID MONOHYDRATE
PROPYLENE GLYCOL
SODIUM BENZOATE
SORBITOL
SUCRALOSE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52083-675	52083-675-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CHLOPHEDIANOL HYDROCHLORIDE	69QQ58998Y	ACTIB
DEXCHLORPHENIRAMINE MALEATE	B10YD955QW	ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SORBITOL	506T60A25R	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 270 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / IRRIGATION		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / EPIDURAL	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SUBCUTANEOUS		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / VAGINAL	0.49 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / ORAL		315 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LOTION / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, ORALLY DISINTEGRATING / ORAL		60 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / ORAL	914 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / TOPICAL	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	GEL / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAMUSCULAR		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRA-ARTICULAR	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TROCHE / ORAL		60 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TROCHE / ORAL	12 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION / ORAL		383 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / NASAL	2.8 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SPRAY / NASAL		2 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET / SUBLINGUAL		12 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, CHEWABLE / ORAL	7 mg		Exact identifier — unii candidate 88 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fe9f1588-4c72-4558-a9f2-114c8ff567f1			99a38bc3-48ad-4d2a-9a10-3f7f57e5401d	2020-06-18	Warnings	Exact identifier spl set id: 99a38bc3-48ad-4d2a-9a10-3f7f57e5401d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.