FDA Label for Doxylamine Succinate And Phenylephrine Hydrochloride
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS? COMMENTS?
- PRINCIPAL DISPLAY PANEL - 100 TABLET BOTTLE LABEL
Doxylamine Succinate And Phenylephrine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Westminster Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
DRUG FACTS
In case of overdose, get medical help or contact a Poison Control Center right away.
Otc - Purpose
| Active ingredients (in each tablet) | Purpose |
|---|---|
| Doxylamine Succinate 7.5mg | Antihistamine |
| Phenylephrine HCl 10mg | Nasal Decongestant |
Uses
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- nasal congestion
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- reduces swelling of nasal passages
Warnings
Do not exceed recommended dosage.
Otc - Do Not Use
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.
Otc - Ask Doctor
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Otc - When Using
When using this product
- exctability may occur, especially in children
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase the drowsiness effect
- use caution when driving a motor vehicle or operating machinery
Otc - Stop Use
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or are accompanied by fever
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Do not exceed recommended dosage.
| Adults and children 12 years of age and over: | 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours. |
| Children 6 to 12 years of age: | 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours. |
| Children 6 years of age and under: | Consult a physician. |
Other Information
Store at 15°-30°C (59°-86°F)
Supplied in a tight, light-resistant container with a child-resistant cap. Doxylamine Succinate and Phenylephrine HCl tablets are light blue, caplet shaped, scored tablets, debossed "WP" bisect "199" on one side and plain on the other.
Inactive Ingredients
FD&C Blue #2 Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Silicone Dioxide, Sodium Starch Glycolate
Questions? Comments?
Call 1-844-221-7294
Principal Display Panel - 100 Tablet Bottle Label
NDC 69367-199-01
Doxylamine Succinate
and Phenylephrine HCl
Antihistamine • Nasal Decongestant
Each tablet contains:
Doxylamine Succinate
7.5 mg
Phenylephrine HCl
10 mg
100 Tablets
Westminster
Pharmaceuticals
* Please review the disclaimer below.