DALLERGY DROPS - chlorpheniramine maleate and phenylephrine hydrochloride liquid
Laser Pharmaceuticals LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Drug Facts
Active ingredients
(in each 1 mL dropperful)
Chlorpehniramine Maleate, 1.0 mg
Phenylephrine Hydrochloride, 2.0 mg
Purpose
Antihistamine, 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
Warnings
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.
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- heart disease
- high blood pressure
- thyroid disease
- diabetes
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
When using this product
- excitability may occur, especially in children
- may cause drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or are accompanied by a fever
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of the reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
· Do not exceed recommended dosage.
· Dosages may be repeated every 4-6 hours if required for relief.
· Use enclosed dropper only. Do not use any other dosage device.
Adults and Children 12 years of age and over:
| 4 dropperfuls (4 mL) every 4-6 hours. Not to exceed more than 6 doses in 24 hours.
|
Children 6 to under 12 years of age:
| 2 dropperfuls (2 mL) every 4-6 hours. Not to exceed more than 6 doses in 24 hours.
|
Children under 6 years of age:
| Consult a doctor
|
Other information
Store at 59° - 86°F (15° - 30° C)
Inactive ingredients
Citric Acid, FD&C Yellow #6, Glycerin, Peach Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.
Questions? Comments?
Call your doctor for medial advice about side effects. Serious side effects associated with this product may be reported to this number.
1-864-286-8229 (Mon-Fri) 8am-5pm EST
Product Packaging
The packaging below represents the labeling currently used.
Principal Display Panel and Side Panel for 30 mL Label:
NDC 16477-120-30
Dallergy DROPS
Sugar Free / Alcohol Free
Antihistamine
Nasal Decongestant
Peach Flavored
Each dropperful (1.0 mL), for oral administration, contains:
Chlorpheniramine Maleate...................... 1.0 mg
Phenylephrine HCl................................ 2.0 mg
1 fl oz (30 mL)
Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.
Supplied in a tight, light-resistant container with a child-resistant closure.
Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC 29615
Manufactured by:
Great Southern Laboratories
Houston, TX 77099
Rev. 05/12