Car - 1133 - 2015-0401
364ec875-1da6-4839-a521-e267e810e8fa
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Description
Drug Facts
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
- sinus congestion and pressure
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Section 50568-5
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Section 50570-1
Do not use 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.
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
| Active ingredients (in each tablet) | Purpose |
|---|---|
| Chlorpheniramine maleate 4 mg | Antihistamine |
| Phenylephrine HCl 10 mg | Nasal decongestant |
Directions
- adults and children 12 years and over: take 1 tablet every 4 hours; do not take more than 6 tablets in 24 hours
- children under 12 years: do not use this product in children under 12 years of age
Other Information
- store at 20°-25°C (68°-77°F)
- retain carton for complete product information
Inactive Ingredients
colloidal silicon dioxide, dibasic dicalcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, pregelatinized starch, sodium starch glycolate, stearic acid
Principal Display Panel
Compare to the Active Ingredients in Sudafed PE® Sinus & Allergy†
CareOne®
Sinus & Allergy PE
Chlorpheniramine Maleate, Antihistamine
Phenylephrine HCl, Nasal Decongestion
Maximum Strength
Sinus Pressure
Sinus & Nasal Congestion
Sneezing
Itchy, Watery Eyes
See New Dosing Directions
24 Tablets
When Using This Product
- do not exceed recommended dosage
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If
- nervousness, dizziness, or sleeplessness occurs
- symptoms do not improve within 7 days or occur with fever
Ask A Doctor Before Use If You Have
- high blood pressure
- heart disease
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Structured Label Content
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
- sinus congestion and pressure
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Section 50570-1 (50570-1)
Do not use 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.
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
| Active ingredients (in each tablet) | Purpose |
|---|---|
| Chlorpheniramine maleate 4 mg | Antihistamine |
| Phenylephrine HCl 10 mg | Nasal decongestant |
Directions
- adults and children 12 years and over: take 1 tablet every 4 hours; do not take more than 6 tablets in 24 hours
- children under 12 years: do not use this product in children under 12 years of age
Other Information (Other information)
- store at 20°-25°C (68°-77°F)
- retain carton for complete product information
Inactive Ingredients (Inactive ingredients)
colloidal silicon dioxide, dibasic dicalcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, pregelatinized starch, sodium starch glycolate, stearic acid
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Compare to the Active Ingredients in Sudafed PE® Sinus & Allergy†
CareOne®
Sinus & Allergy PE
Chlorpheniramine Maleate, Antihistamine
Phenylephrine HCl, Nasal Decongestion
Maximum Strength
Sinus Pressure
Sinus & Nasal Congestion
Sneezing
Itchy, Watery Eyes
See New Dosing Directions
24 Tablets
When Using This Product (When using this product)
- do not exceed recommended dosage
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- nervousness, dizziness, or sleeplessness occurs
- symptoms do not improve within 7 days or occur with fever
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- high blood pressure
- heart disease
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:55:56.076266 · Updated: 2026-03-14T22:53:59.046955