Cold and Cough

Manufacturer: Rite Aid Corporation
Effective date: 2024-11-11
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 20:49:41

Label at a glance#

ProductCold and Cough Childrens

Active ingredientBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (Allergic rhinitis) runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily restores freer breathing through the nose

Dosage and administration

do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product mL = milliliter Age Dose adults and children 12 years and over 20 mL every 4 hours children 6 to 11 years 10 mL every 4 hours children under 6 years do not use

Contacts and useful links#

PhonePoison Help1-800-222-1222

Websitewww.riteaid.com

www.riteaid.com

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Brompheniramine Maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves these symptoms due to hay fever (Allergic rhinitis)
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

to sedate a child or to make a child sleepy
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

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other oral nasal decongestant or stimulant
taking sedatives or tranquilizers

When using this product,

OTC - WHEN USING SECTION

do not use more than directed
marked drowsiness may occur
avoid alcoholic beverages
alcohol,sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

nervousness, dizziness or sleeplessness occur
symptoms do not improve within 7 days or are accompanied by fever
cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.These could be a sign of a serious condition

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device
keep dosing cup with product
mL = milliliter

Age	Dose
adults and children 12 years and over	20 mL every 4 hours
children 6 to 11 years	10 mL every 4 hours
children under 6 years	do not use

Other information

OTHER SAFETY INFORMATION

each 10 mL contains: sodium 5 mg
store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Children's Dimetapp® Cold & Cough*

6 YEARS & OLDER

CHILDREN'S

COLD & COUGH

BROMPHENIRAMINE MALEATE 2 mg

DEXTROMETHORPHAN HBr 10 mg

PHENYLEPHRINE HCl 5 mg

ANTIHISTAMINE

COUGH SUPPRESSANT

NASAL DECONGESTANT

relieves:

cough • itchy, watery eyes

runny nose • sneezing

stuffy nose

itching of the nose or throat

GRAPE FLAVOR

DOSAGE CUP INCLUDED

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Children's Dimetapp® Cold & Cough.

DISTRIBUTED BY:

RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

www.riteaid.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RITE AID Children's Cold & Cough Grape Flavor

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1090463	Brompheniramine/Dextromethorphan/Phenylephrine (Oral Liquid)	brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD Active

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-5259	COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [RITE AID CORPORATION]	3	Legacy NDC	20241113_35a06615-edf0-4914-87f6-95ad92d5f24d.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Cold and Cough Childrens
Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl
BROMPHENIRAMINE MALEATE
BROMPHENIRAMINE
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE
SORBITOL
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11822-5259	11822-5259-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BROMPHENIRAMINE MALEATE	IXA7C9ZN03	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
TRISODIUM CITRATE DIHYDRATE	B22547B95K	IACT
SORBITOL	506T60A25R	IACT
SUCRALOSE	96K6UQ3ZD4	IACT

Source Document#

Source XML

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
8e79e692-8c2d-424b-a1bf-4740435840bd			35a06615-edf0-4914-87f6-95ad92d5f24d	2024-11-11	Warnings	Exact identifier spl id: 8e79e692-8c2d-424b-a1bf-4740435840bd spl set id: 35a06615-edf0-4914-87f6-95ad92d5f24d

Reported adverse events (FAERS/openFDA)#

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