Cold and Allergy

Manufacturer: Care One (American Sales Company)
Effective date: 2019-10-29
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 00:04:36

Label at a glance#

ProductCold and Allergy

Active ingredientCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

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

Dosage and administration

take every 4 hours do not take more than 6 doses in 24 hours adults and children 12 years of age and older take 1 tablet children 6 to under 12 years of age take 1/2 tablet children under 6 years of age consult a doctor children under 4 years of age do not use

Contacts and useful links#

PhoneLabel contact1-877-753-3935

PhoneLabel contact1-877-846-9949

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate 4 mg

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- nasal congestion
- itching of the nose or throat
temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
- nasal congestion

Warnings

WARNINGS SECTION

Do not use

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

high blood pressure
heart disease
thyroid disease
diabetes
glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland

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

do not use more than directed
excitability may occur, especially in children
drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
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
symptoms do not improve within 7 days or occur with a fever

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

take every 4 hours
do not take more than 6 doses in 24 hours

adults and children 12 years of age and older	take 1 tablet
children 6 to under 12 years of age	take 1/2 tablet
children under 6 years of age	consult a doctor
children under 4 years of age	do not use

Other information

OTHER SAFETY INFORMATION

each tablet contains: calcium 10 mg
store between 15-30^oC (59-86^o F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch,dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, sodium starch glycolate and stearic acid.

Question or Comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COLD & ALLERGY RELIEF

Antihistamine - Chlorpheniramine Maleate, 4 mg

Nasal Decongestant - Phenylephrine HCI, 10 mg

For Relief of:

Nasal Congestion

Runny Nose

Itchy, Watery Eyes

Sneezing

Gluten Free

TABLETS

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY FOODHOLD, U.S.A., LLC

LANDOVER, MD 20785 • 1-877-846-9949

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1090443	Chlorpheniramine/Phenylephrine (Oral Pill)	chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD Active

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	1
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1

Products#

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

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

Cold and Allergy
Chlorpheniramine maleate, Phenylephrine HCl
CHLORPHENIRAMINE MALEATE
CHLORPHENIRAMINE
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
SILICON DIOXIDE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
MINERAL OIL
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41520-890	41520-890-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CHLORPHENIRAMINE MALEATE	V1Q0O9OJ9Z	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	L11K75P92J	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
MINERAL OIL	T5L8T28FGP	IACT
STARCH, CORN	O8232NY3SJ	IACT
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	IACT
STEARIC ACID	4ELV7Z65AP	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 4 · 236 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, CHEWABLE / ORAL	50 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	INSERT / VAGINAL	54.21 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION/ DROPS / OPHTHALMIC		3 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, DELAYED RELEASE / ORAL	5.67 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET / SUBLINGUAL		28 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		21 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION, EXTENDED RELEASE / ORAL		113 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION/ DROPS / ORAL		90 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, CHEWABLE / ORAL	11.8 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	PASTE, DENTIFRICE / DENTAL	48.36 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, COATED / ORAL	1.5 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	CREAM / TOPICAL	36 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TROCHE / ORAL		300 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, DELAYED RELEASE / ORAL	789.6 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 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
baafc63c-cb2b-4605-9ae7-2901c843ba3e			e00a336f-09b8-4421-bee3-cfbc2c491f09	2019-10-29	Warnings	Exact identifier spl id: baafc63c-cb2b-4605-9ae7-2901c843ba3e spl set id: e00a336f-09b8-4421-bee3-cfbc2c491f09

Reported adverse events (FAERS/openFDA)#

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