CHILDRENS DELSYM COUGH PLUS COLD DAY TIME- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution

Childrens Delsym by

Drug Labeling and Warnings

Childrens Delsym by is a Otc medication manufactured, distributed, or labeled by Reckitt Benckiser LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 10 mL)	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses
- temporarily relieves these common cold and flu symptoms:
  - cough
  - nasal congestion
  - sinus congestion and pressure
  - minor aches and pains
  - sore throat
  - headache
- temporarily reduces fever
- temporarily promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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.
- 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
- 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

When using this product do not use more than directed
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 (adult)
- 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

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 dihydrate1, xanthan gum

1 may contain this ingredient

Questions?

1-888-963-3382

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. By: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in England

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

Children's
Delsym®

NDC: 63824-216-66

COUGH +™ COLD

DAY TIME

Acetaminophen (Pain Reliever/Fever Reducer)
Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)
Phenylephrine HCl (Nasal Decongestant)

Age 6+

✓ Cough
✓ Fever
✓ Sore Throat
✓ Headache
✓ Nasal & Chest Congestion

6 fl oz (180 mL)
Berry Flavor

021014
3002719

Principal Display Panel - 180 mL Bottle Label

INGREDIENTS AND APPEARANCE

CHILDRENS DELSYM COUGH PLUS COLD DAY TIME
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-216
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D)	acetaminophen	325 mg in 10 mL
dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS)	dextromethorphan hydrobromide	10 mg in 10 mL
guaifenesin (UNII: 495W7451VQ) (guaifenesin - UNII:495W7451VQ)	guaifenesin	200 mg in 10 mL
phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV)	phenylephrine hydrochloride	5 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
anhydrous citric acid (UNII: XF417D3PSL)
edetate disodium (UNII: 7FLD91C86K)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
FD&C Red No. 40 (UNII: WZB9127XOA)
glycerin (UNII: PDC6A3C0OX)
propylene glycol (UNII: 6DC9Q167V3)
propyl gallate (UNII: 8D4SNN7V92)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)
trisodium citrate dihydrate (UNII: B22547B95K)
xanthan gum (UNII: TTV12P4NEE)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 63824-216-66	180 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	04/01/2014

Labeler - Reckitt Benckiser LLC (094405024)