Chlo Tuss

Manufacturer: R.A. McNeil Company
Effective date: 2025-10-15
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 01:39:09

Label at a glance#

ProductChlo Tuss

Active ingredientCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE

Label structure8 sections

Indications and uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat and bronchial irritation runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages

Dosage and administration

Do not exceed recommended dosage. Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teaspoonfuls in 24 hours Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls in 24 hours Children under 6 years of age: Consult a doctor

Storage and handling

Store at 59° - 86°F (15° - 30°C)

Contacts and useful links#

PhoneLabel contact1-423-493-9170

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each 5 mL teaspoonful)

Chlophedianol Hydrochloride 12.5 mg

Dexbrompheniramine Maleate 1 mg

Pseudoephedrine Hydrochloride 30 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Antihistamine

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

cough due to minor throat and bronchial irritation
runny nose
sneezing
itching of the nose or throat
itchy, watery eyes
nasal congestion
reduces swelling of nasal passages

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use this product

OTC - DO NOT USE SECTION

if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
a cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
heart disease
high blood pressure
thyroid disease
diabetes

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

excitability may occur, especially in children
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase the drowsiness effect
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

nervousness, dizziness, or sleeplessness occur
cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
new symptoms occur

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.


Adults and children 12 years of age and over:	2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teaspoonfuls in 24 hours
Children 6 to under 12 years of age:	1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls in 24 hours
Children under 6 years of age:	Consult a doctor

Other information

STORAGE AND HANDLING SECTION

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Tutti Frutti Flavor.

Questions? Comments?

OTC - QUESTIONS SECTION

Serious side effects associated with use of this product may be reported to this number. Call 1-423-493-9170
(8 a.m. to 5 p.m.)

PRODUCT PACKAGING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

front

back

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1441376	Chlophedianol/Dexbrompheniramine/Pseudoephedrine (Oral Liquid)	chlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1441376	chlophedianol HCl 12.5 MG / dexbrompheniramine maleate 1 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution	PSN	9
1441376	chlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	9
1441376	chlophedianol HCl 12.5 MG / dexbrompheniramine maleate 1 MG / pseudoephedrine HCl 30 MG per 5 ML Oral Solution	SY	9
1441376	chlophedianol HCl 25 MG / dexbrompheniramine maleate 2 MG / pseudoephedrine HCl 60 MG per 10 ML Oral Solution	SY	9
1441376	chlophedianol HCl 6.25 MG / dexbrompheniramine maleate 0.5 MG / pseudoephedrine HCl 15 MG per 2.5 ML Oral Solution	SY	9

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PSEUDOEPHEDRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
12830-762-15	2024-03-19	C162847	48780-1	e4f33bdf-aae6-d8a0-e053-dadaa90a6e4e	Chlo Tuss
12830-762-15	2024-03-19	C162847	48780-1	e4f33bdf-aae6-d8a0-e053-dadaa90a6e4e	Chlo Tuss
12830-762-16	2024-03-19	C162847	48780-1	e4f33bdf-aae6-d8a0-e053-dadaa90a6e4e	Chlo Tuss
12830-762-16	2024-03-19	C162847	48780-1	e4f33bdf-aae6-d8a0-e053-dadaa90a6e4e	Chlo Tuss
12830-762-15	2024-01-30	C162847	48780-1	e4f33bdf-aae6-d8a0-e053-dadaa90a6e4e	Chlo Tuss
12830-762-15	2024-01-30	C162847	48780-1	e4f33bdf-aae6-d8a0-e053-dadaa90a6e4e	Chlo Tuss
12830-762-16	2024-01-30	C162847	48780-1	e4f33bdf-aae6-d8a0-e053-dadaa90a6e4e	Chlo Tuss
12830-762-16	2024-01-30	C162847	48780-1	e4f33bdf-aae6-d8a0-e053-dadaa90a6e4e	Chlo Tuss
12830-762-15	2022-12-22	C162847	48780-1	e4f33bdf-aae6-d8a0-e053-dadaa90a6e4e	Chlo Tuss
12830-762-15	2022-12-22	C162847	48780-1	e4f33bdf-aae6-d8a0-e053-dadaa90a6e4e	Chlo Tuss
12830-762-16	2022-12-22	C162847	48780-1	e4f33bdf-aae6-d8a0-e053-dadaa90a6e4e	Chlo Tuss
12830-762-16	2022-12-22	C162847	48780-1	e4f33bdf-aae6-d8a0-e053-dadaa90a6e4e	Chlo Tuss
12830-762-15	2022-07-29	C162847	48780-1	e4f33bdf-aae6-d8a0-e053-dadaa90a6e4e	Chlo Tuss
12830-762-15	2022-07-29	C162847	48780-1	e4f33bdf-aae6-d8a0-e053-dadaa90a6e4e	Chlo Tuss
12830-762-16	2022-07-29	C162847	48780-1	e4f33bdf-aae6-d8a0-e053-dadaa90a6e4e	Chlo Tuss
12830-762-16	2022-07-29	C162847	48780-1	e4f33bdf-aae6-d8a0-e053-dadaa90a6e4e	Chlo Tuss

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
12830-762-15	Chlo Tuss	15 mL in 1 BOTTLE	LIQUID	15		9
12830-762-16	Chlo Tuss	473 mL in 1 BOTTLE	LIQUID	473		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
12830-762-16	ML - Milliliter	12830-762	439eb45c-6244-49a3-a05d-4394fe9dcbd4	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Chlophedianol Hydrochloride	ACTIVE INGREDIENT	69QQ58998Y	2
Dexbrompheniramine Maleate	ACTIVE INGREDIENT	BPA9UT29BS	2
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	2
Chlophedianol	ACTIVE MOIETY	42C50P12AP	2
Dexbrompheniramine	ACTIVE MOIETY	75T64B71RP	2
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	2
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	2
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	2
Sorbitol	INACTIVE INGREDIENT	506T60A25R	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Chlo Tuss
Chlophedianol Hydrochloride, Dexbrompheniramine Maleate, Pseudoephedrine Hydrochloride
CITRIC ACID MONOHYDRATE
GLYCERIN
PROPYLENE GLYCOL
WATER
SODIUM CITRATE
SACCHARIN SODIUM
SORBITOL
CHLOPHEDIANOL HYDROCHLORIDE
CHLOPHEDIANOL
DEXBROMPHENIRAMINE MALEATE
DEXBROMPHENIRAMINE
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
12830-762	12830-762-16, 12830-762-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBITOL	506T60A25R	IACT
CHLOPHEDIANOL HYDROCHLORIDE	69QQ58998Y	ACTIB
DEXBROMPHENIRAMINE MALEATE	BPA9UT29BS	ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
8	2024-03-18	full-release	2026-06-01 00:10:01

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 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL	29008 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL	3 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	LIQUID / ORAL	53460 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL	2400 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL	2400 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL	3 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL	3 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL	2400 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL	29008 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	LIQUID / ORAL	53460 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL	114 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL	114 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	LIQUID / ORAL	53460 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL	29008 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL	114 mg	Exact identifier — unii+route+dosage form 3 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
Chlo Tuss	CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	R.A. McNeil Company	43610aaa-8b94-40d5-ae09-3d75bd2317c8	2025-10-15	Warnings	Exact identifier ndc (package): 12830-762-16 ndc (package): 12830-762-15 ndc (product): 12830-762 ndc11 (package): 12830076216 ndc11 (package): 12830076215 spl id: 413d58e3-7690-f93d-e063-6394a90a2344 spl set id: 43610aaa-8b94-40d5-ae09-3d75bd2317c8

Reported adverse events (FAERS/openFDA)#

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