CVS - CHILDRENS STUFFY NOSE AND COLD - guaifenesin and phenylephrine hydrochloride solution
CVS Pharmacy, Inc.
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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CVS - Children's Stuffy Nose and Cold
Drug Facts
Active ingredients (in each 5 mL (1 tsp) dose)
Guaifenesin, USP 100 mg
Phenylephrine HCl, USP 2.5 mg
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- nasal congestion due to a cold
- stuffy nose
Warnings
Do not use in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Avoid foods or beverages that contain caffeine.
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
Stop use and ask a doctor if
- your child gets nervous, dizzy or sleepless
- symptoms do not get better within 7 days or occur with fever
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.
These could be signs of a serious illness.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- measure only with dosing cup provided
- do not use dosing cup with other products
- mL= milliliter; tsp = teaspoon
| Age
| Dose
|
| Children 6 years to 12 years | 10 mL (2 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours |
| Children 4 years to 6 years | 5 mL (1 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours |
| Children under 4 years | do not use unless directed by a doctor
|
Other information
- each 5 mL contains: sodium 3 mg
- tamper evident: do not use if printed seal under cap is torn or missing
- store at 20-25°C (68-77°F)
- do not refrigerate
- dosing cup provided
- see bottom panel for lot number and expiration date
Inactive ingredients
anhydrous citric acid, edetate disodium, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.
Questions or Comments?
1-855-274-4122
You may also report side effects to this phone number.
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive,
Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Product of India V-32402
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)
CVS
HealthTM
Compare to the
active ingredients in
Children’s Mucinex®
Stuffy Nose & Cold*
NDC 59779-454-24
Children's
Stuffy Nose
& Cold
Each 5 mL (1 tsp) dose of oral
solution contains:
GUAIFENESIN, USP 100 mg
Expectorant
PHENYLEPHRINE HCl, USP 2.5 mg
Nasal decongestant
Relieves:
• Stuffy Nose
• Chest congestion
• Breaks up mucus
Alcohol free
For Ages 4+
Mixed Berry Flavor Syrup
Dosage cup included
Actual Bottle Size on Side Panel
4 FL OZ (118 mL)
| CVS - CHILDRENS STUFFY NOSE AND COLD
guaifenesin and phenylephrine hydrochloride solution |
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| Labeler - CVS Pharmacy, Inc. (062312574) |
| Registrant - Aurohealth LLC (078728447) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Aurohealth LLC | 078728447 | MANUFACTURE(59779-454) | |