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FDA LABEL GENERIC: Acetaminophen MFR: Reckitt Benckiser LLC

1 Daytime (dextromethorphan Hbr 5 Mg / Guaifenesin 100 Mg In 5 Ml Oral Solution) / 1 Nighttime (acetaminophen 325 Mg / Diphenhydramine Hcl 12.5 Mg / Phenylephrine Hcl 5 Mg In 10 Ml Oral Solution) Pack

COUGH+ CHEST CONGESTION DM - AGES 4+

Drug Facts

Active ingredients (in each 5 mL) Purposes
Dextromethorphan HBr 5 mg Cough suppressant
Guaifenesin 100 mg Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep

Warnings

Do not usein 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 the child has

persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus)

When using this product do not use more than directed

Stop use and ask a doctor if

cough lasts more than 7 days, 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

do not give more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor
Age (year) Dose (mL)
children 6 to under 12 years of age 5 mL – 10 mL every 4 hours
children 4 to under 6 years of age 2.5 mL – 5 mL every 4 hours
children under 4 years of age do not use

Other information

each 5 mL contains: sodium 3 mg store between 20-25°C (68-77°F) do not refrigerate

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate may contain this ingredient, xanthan gum

COUGH+ COLD NIGHT TIME - AGES 6+

Drug Facts

Active ingredients (in each 10 mL) Purpose
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: cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help your child get to sleep

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

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening blisters rash

If a skin reaction occurs, stop use and seek medical help right away.

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 product 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 the 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 the child is

taking the blood thinning drug warfarin taking sedatives or tranquilizers

When using this product

do not use more than directed (see Overdose warning) 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 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) measure only with the dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; not to exceed 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) do not refrigerate

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihyrate may contain this ingredient, xanthan gum

Questions?

1-866-682-4639

You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser

Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 63824-218-22

DAY

NIGHT

COMBO

PACK

Children's

Delsym ®

COUGH+ ®

Chest Congestion

DM

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

Relieves Cough Relieves Chest

Congestion
Thins &

Loosens

Mucus

Cherry Flavor

For Ages

4

years+

COUGH+ ®Cold

Night Time

Acetaminophen (Pain Reliever/Fever Reducer)

Diphenhydramine HCl (Antihistamine/Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves Cough Relieves

Stuffy Nose
Relieves

Sore Throat
Reduces Fever

Berry Flavor

For Ages

6

years+

TWO - 4 fl oz (118 mL) bottles TOTAL - 8 fl oz (236 mL)