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Sprinsol - Medication Information

Product NDC Code 51467-101
Drug Name

Sprinsol

Type Brand
Pharm Class Histamine H1 Receptor Antagonists [MoA],
Histamine-1 Receptor Antagonist [EPC]
Active Ingredients
Chlorpheniramine maleate 4 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 1363309
Application Number part341
Labeler Name FORTUNE PHARMACAL COMPANY LIMITED
Packages
Package NDC Code Description
51467-101-01 2 blister pack in 1 box (51467-101-01) / 12 tablet in 1 blister pack
51467-101-02 3 blister pack in 1 box (51467-101-02) / 12 tablet in 1 blister pack
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients (in each tablet) Chlorpheniramine maleate 4 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions adults and children 12 years of age and over: take 1 tablet every 4 to 6 hours, not to exceed 6 tablets (24 mg) in 24 hours, or as directed by a doctor children under 12 years of age: consult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients colloidal silicon dioxide, corn starch, FD C red no. 40 aluminum lake, lactose monohydrate, magnesium stearate, povidone K30, sodium starch glycolate

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: sneezing runny nose itching of the nose or throat itchy, watery eyes

Purpose

Information about the drug product’s indications for use.
Purpose Antihistamine

Spl product data elements

Usually a list of ingredients in a drug product.
SPRINSOL Chlorpheniramine maleate CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE SILICON DIOXIDE STARCH, CORN FD&C RED NO. 40 LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO FORTUNE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Sprinsol Safely Sealed NDC 51467-101-02 Chlorpheniramine maleate - Antihistamine temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: sneezing runny nose itching of the nose or throat itchy, watery eyes 36 Tablets In Individually Sealed Strip Respiratory Series IMAGE OF CARTON

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information keep tightly sealed protect from light store between 20 to 25 C (68 to 77 F)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? (888) 221-3496 M-F 9 am to 5 pm you may also report serious side effects to this phone number

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product do not exceed recommended dosage unless directed by a physician may cause excitability especially in children use caution when driving or operating machinery avoid alcoholic beverages may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API