RxNorm Names
Review RxNorm Normal Forms
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE solution/ drops
[Akorn, Inc.]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=78c5250c-b27c-4b1d-a4b8-571973ac3ae4| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | Abbreviated New Drug Application |
Warnings:
For external use only
Ask a doctor before use if you have
- heart disease
- high blood pressure
- narrow angle glaucoma
- trouble urinating due to an enlarged prostate gland
When using this product
- pupils may become enlarged temporarily
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
- remove contact lenses before using
- do not use if this solution changes color or become cloudy
- overuse may cause more eye redness
Directions
- adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to four times a day
- children under 6 years of age: consult a doctor
Other information
- some users may experience a brief tingling sensation
- store between 20° to 25°C (68° to 77°F)
Inactive ingredients
Boric Acid and Sodium Borate buffer system preserved with Benzalkonium Chloride (0.01%) and Edetate Disodium (0.1%),Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH) and Water for Injection.
Principal Display Panel Text for Container Label:
NDC 17478-065-12
Naphazoline HCl 0.025%
and
Pheniramine Maleate 0.3%
Ophthalmic Solution, USP
ANTIHISTAMINE & REDNESS
RELIEVER
Eye Allergy
Relief Eye Drops
Sterile
15 mL (0.5 fl. oz.)
Principal Display Panel Text for Carton Label:
NDC 17478-065-12
Naphazoline HCl 0.025%
and
Pheniramine Maleate 0.3%
Ophthalmic Solution, USP
ANTIHISTAMINE & REDNESS
RELIEVER
Eye Allergy
Relief Eye Drops
► Relives Redness
► Relieves itchy Eyes Due To:
Pollen ● Ragweed ● Grass
Animal Hair & Dander
Sterile
15 mL (0.5 fl. oz.)
| NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
naphazoline hydrochloride and pheniramine maleate solution/ drops |
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| Labeler - Akorn, Inc. (062649876) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Akorn, Inc | 063434679 | PACK(17478-065), LABEL(17478-065) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Akorn, Inc. | 155135783 | MANUFACTURE(17478-065), ANALYSIS(17478-065), STERILIZE(17478-065) | |
