FDA Label for Ru-hist D
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- OTC - WHEN USING
- DO NOT USE THIS PRODUCT
- OTC - ASK DOCTOR
- OTC - DO NOT USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 60 TABLET BOTTLE LABEL
Ru-hist D Product Label
The following document was submitted to the FDA by the labeler of this product Allegis 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
Otc - Purpose
| Active Ingredients Each tablet contains: | Purpose |
|---|---|
| Brompheniramine Maleate 4 mg | Antihistamine |
| Phenylephrine HCl 10 mg | Nasal Decongestant |
Uses
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- nasal congestion
- reduces swelling of nasal passages
Otc - When Using
Do not exceed recommended dosage.
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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- heart disease
- high blood pressure
- thyroid disease
- diabetes mellitus
- difficulty in urination due to enlargement of the prostate gland
Otc - Do Not Use
Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.
When Using This Product
- excitability may occur, especially in children
- may cause drowsiness
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- if symptoms do not improve within 7 days or are accompanied by fever
- new symptoms occur
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.
In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
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, or as directed by a doctor |
| Children 6 to under 12 years of age: | 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor |
| Children under 6 years of age: | Consult a doctor |
Other Information
Store at 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Inactive Ingredients
Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate
Questions Or Comments?
Call 866-633-9033
Principal Display Panel - 60 Tablet Bottle Label
NDC 28595-900-60
Ru-Hist D
Antihistamine • Nasal Decongestant
Each tablet contains:
Brompheniramine Maleate 4 mg
Phenylephrine HCl 10 mg
Tamper evident by foil seal under cap. Do not use if foil seal
is broken or missing.
New Formula
ALLEGIS PHARMACEUTICALS
Manufactured for:
Allegis Pharmaceuticals, LLC
Canton, MS 39046
60 Tablets
* Please review the disclaimer below.