3e87d0f3-f16c-5972-e063-6294a90acc8a
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredients (in each tablet) Pseudoephedrine HCl 60 mg Pyrilamine Maleate 30 mg
Medication Information
Warnings and Precautions
Warnings
Do not exceed recommended dosage.
May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.
Indications and Usage
Uses
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- nasal congestion
- runny nose
- itchy watery eyes
- itching of the nose and throat
Dosage and Administration
Directions:
Do not exceed recommended dosage.
| Adults and Children
12 years of age and over: |
1 tablet every 6/8 hours.
Do not exceed 4 tablets in 24 hours. |
| Children 6-12 years
of age: |
1/2 tablet every 6/8 hours.
Do not exceed 2 tablets in 24 hours. |
Description
Active ingredients
(in each tablet)
Pseudoephedrine HCl 60 mg
Pyrilamine Maleate 30 mg
Section 34088-5
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9
Stop use and ask a doctor if
- cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
- new symptoms occur
Section 50569-3
Ask a doctor before use if you have
- a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- a cough that occurs with too much phlegm (mucus)
- heart disease
- thyroid disease
- diabetes
- trouble urinating due to enlargement of the prostate gland
Section 50570-1
Do not use this product 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 51727-6
Carnauba Wax, Croscarmellose Sodium, FD&C Yellow #6 Aluminum Lake, Iron Oxide Yellow, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Silicon Dioxide, Talc, Titanium Dioxide.
Section 51945-4
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Decongestant, Antihistamine
Section 55106-9
Pseudoephedrine HCL
Pyrilamine Maleate
Section 60561-8
Questions? Comments?
Serious side effects may be reported to this number.
Call 1 (614) 638-4622
Structured Label Content
Indications and Usage (34067-9)
Uses
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- nasal congestion
- runny nose
- itchy watery eyes
- itching of the nose and throat
Dosage and Administration (34068-7)
Directions:
Do not exceed recommended dosage.
| Adults and Children
12 years of age and over: |
1 tablet every 6/8 hours.
Do not exceed 4 tablets in 24 hours. |
| Children 6-12 years
of age: |
1/2 tablet every 6/8 hours.
Do not exceed 2 tablets in 24 hours. |
Warnings and Precautions (34071-1)
Warnings
Do not exceed recommended dosage.
May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.
Section 34088-5 (34088-5)
Description (34089-3)
Active ingredients
(in each tablet)
Pseudoephedrine HCl 60 mg
Pyrilamine Maleate 30 mg
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.
Section 50566-9 (50566-9)
Stop use and ask a doctor if
- cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
- new symptoms occur
Section 50569-3 (50569-3)
Ask a doctor before use if you have
- a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- a cough that occurs with too much phlegm (mucus)
- heart disease
- thyroid disease
- diabetes
- trouble urinating due to enlargement of the prostate gland
Section 50570-1 (50570-1)
Do not use this product 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 51727-6 (51727-6)
Carnauba Wax, Croscarmellose Sodium, FD&C Yellow #6 Aluminum Lake, Iron Oxide Yellow, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Silicon Dioxide, Talc, Titanium Dioxide.
Section 51945-4 (51945-4)
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Decongestant, Antihistamine
Section 55106-9 (55106-9)
Pseudoephedrine HCL
Pyrilamine Maleate
Section 60561-8 (60561-8)
Questions? Comments?
Serious side effects may be reported to this number.
Call 1 (614) 638-4622
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:08:46.887671 · Updated: 2026-03-14T23:13:09.195902