Childrens Delsym
Children's Delsym Cough Plus™ Cold Night Time
FULL PRESCRIBING INFORMATION: CONTENTS*
- Childrens Delsym Uses
- Warnings
- Directions
- Childrens Delsym Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label
FULL PRESCRIBING INFORMATION
Drug Facts
Active ingredient
Purpose
| 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 |
Childrens Delsym Uses
- temporarily relieves these common cold and flu symptoms:
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- runny nose
- sneezing
- temporarily reduces fever
- controls cough to help you get to sleep
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 6 doses in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks daily while using this product
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
- 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 the user has
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma
- breathing problems such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if the user 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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
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 (children) or 7 days (adults)
- 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.
If pregnant or breast-feeding, ask a health professional before use.
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
- do not take more than directed (see Overdose warning)
- 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
| Age (year) | Dose (mL) |
|---|---|
| adults and children 12 years of age and older | 20 mL every 4 hours; do not take more than 6 doses in any 24-hour period |
| children 6 to under 12 years of age | 10 mL every 4 hours; do not take more than 5 doses in any 24-hour period |
| children under 6 years of age | do not use |
Childrens Delsym Other information
- each 10 mL contains: sodium 6 mg
- tamper evident: do not use if neckband on bottle cap is broken or missing
- store between 20-25°C (68-77°F)
- do not refrigerate
- dosing cup provided
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 dihydrate
Questions?
1-888-963-3382
You may also report side effects to this phone number.
Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in England
PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label
031113
8078735
NEW
INGREDIENT
Children's
Delsym®
NDC 63824-212-66
COUGH + ™ COLD
NIGHT TIME
Acetaminophen (Pain Reliever/Fever Reducer)
Diphenhydramine HCl (Antihistamine/Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
Age 6+
-
✓ Cough -
✓ Fever -
✓ Stuffy Nose -
✓ Sore Throat
6 fl oz (180 mL)
Berry Flavor
Childrens DelsymAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride LIQUID
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