CHILDRENS MUCINEX NIGHT TIME MULTI-SYMPTOM COLD- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride solution
RB Health (US) 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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Active ingredients (in each 10 mL) | Purposes |
Acetaminophen 325 mg | Pain reliever/fever reducer |
Diphenhydramine HCl 12.5 mg | Antihistamine/cough suppressant |
Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
- temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- runny nose
- sneezing
- cough
- controls cough to help your child get to sleep
- temporarily reduces fever
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
Sore throat warning
if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- to make a child sleepy
- with any other drug containing diphenhydramine, even one used on the skin
- 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.
Ask a doctor before use if your child has
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- glaucoma
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if your child is
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
-
do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 5 days
- fever gets worse, or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
-
this product does not contain directions or complete warnings for adult use
-
do not give more than directed (see Overdose warning)
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 days unless directed by a doctor
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- mL = milliliter
- children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours; do not give more than 5 doses in any 24-hour period
- children under 6 years of age: do not use
Other information
- each 10 mL contains: sodium 6 mg
- store between 20-25°C (68-77°F)
- dosing cup provided
- do not refrigerate
Inactive ingredients
anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum
Questions?
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224
Made in England
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
New!
NDC 63824-600-64
Children's
Mucinex®
NIGHT TIME
Multi-Symptom
Cold
Pain Reliever/Fever Reducer
Antihistamine/Cough Suppressant
Nasal Decongestant
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
✓ Stuffy Nose
✓ Cough
✓ Runny Nose & Sneezing
✓ Fever & Sore Throat
Age 6+
Mixed Berry
Flavor Liquid
4 FL OZ
(118 mL)