Children's Cold + Cough + Sore Throat Relief
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - PURPOSE SECTION
| Acetaminophen 160 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 5 mg | Cough suppressant |
Uses
- ▪temporarily relieves the following cold/flu symptoms: ▪minor aches and pains▪headache▪sore throat▪cough
- ▪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
SPL UNCLASSIFIED SECTION
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
- ▪skin reddening
- ▪blisters
- ▪rash
SPL UNCLASSIFIED SECTION
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.
- ▪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.
- ▪if your child has ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if your child has
- ▪liver disease
- ▪persistent or chronic cough such as occurs with asthma
- ▪cough that occurs with too much phlegm (mucus)
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product
- ▪do not exceed recommended dose (see overdose warning)
Stop use and ask a doctor if
These could be signs of a serious condition.
- ▪pain or cough gets worse or lasts more than 5 days
- ▪fever gets worse or lasts more than 3 days
- ▪new symptoms occur
- ▪redness or swelling is present
- ▪cough comes back or occurs with rash or headache that lasts
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
| under 36 | under 4 years | do not use |
| 36-47 | 4 to 5 years | 5 mL |
| 48-95 | 6 to 11 years | 10 mL |
- ▪this product does not contain directions or complete warnings for adult use
- ▪do not give more than directed (see overdose warning)
- ▪shake well before using
- ▪mL = milliliter
- ▪find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
- ▪remove the child protective cap and squeeze your child's dose into the dosing cup
- ▪repeat dose every 4 hours, while symptoms last
- ▪do not give more than 5 times in 24 hours
Other information
- •each 5 mL contains: sodium 3 mg
- •store at room temperature
Inactive ingredients
carboxymethylcellulose sodium, anhydrous citric acid, D&C red no. 33, disodium edetate, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum