Indications and uses
• temporarily relieves the following cold/flu symptoms: • minor aches and pains • headache • sore throat • sneezing and runny nose • cough • stuffy nose • temporarily reduces fever
childrens pain relief cold and flu
- Manufacturer
- Rite Aid Corporation
- Effective date
- 2019-09-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:12:12
Label at a glance#
Productchildrens pain relief cold and flu
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
• 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 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 t...
Storage and handling
• each 5 mL contains: sodium 3 mg • store at 20-25 ° C (68-77 ° F). • do not use if printed neckband is broken or missing
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each 5 mL)
Acetaminophen 160 mg
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCl 2.5 mg
Purpose
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- sneezing and runny nose
- cough
- stuffy nose
- 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
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
- 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as chronic bronchitis
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 exceed recommended dosage (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 rash or headache that lasts. These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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)
- shake well before using
- mL = milliliter
- find 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
Weight (lb) | Age (yr) | Dose (mL)* |
under 36 | under 4 years | do not use |
36-47 | 4 to 5 years | do not use unless directed by a doctor |
48-95 | 6 to 11 years | 10 mL |
* or as directed by a doctor
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other information
- each 5 mL contains: sodium 3 mg
- store at 20-25°C (68-77°F).
- do not use if printed neckband is broken or missing
Inactive ingredients
anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, tribasic sodium phosphate, xanthan gum
Questions or comments?
1-800-719-9260
Package/Label Principal Display Panel
Compare to the active ingredients of Children’s Tylenol® Cold + Flu Oral Suspension
FOR AGES 6-11 YEARS
CHILDREN’S PAIN RELIEF COLD & FLU
ACETAMINOPHEN
PAIN RELIEVER/FEVER REDUCER
CHLORPHENIRAMINE MALEATE
ANTIHISTAMINE
DEXTROMETHORPHAN HBr
COUGH SUPPRESSANT
PHENYLEPHRINE HCl
NASAL DECONGESTANT
oral suspension
relieves fever, sore throat, sneezing, runny nose, cough, and stuffy nose
alcohol free - aspirin free
ibuprofen free – gluten free
GRAPE FLAVOR
DOSAGE CUP INCLUDED
4 FL OZ (118 mL)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11822-1023-1 | 2024-07-25 | C162847 | 48780-1 | f386c649-ed4e-0266-e053-dadaa90a7c1a | Rite Aid Corporation Children’s Pain Relief Cold & Flu Drug Facts |
| 11822-1023-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-ed4e-0266-e053-dadaa90a7c1a | Rite Aid Corporation Children’s Pain Relief Cold & Flu Drug Facts |
Products#
Every source-derived product name is available through these pages.
- childrens pain relief cold and flu
- Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl
- ACETAMINOPHEN
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ANHYDROUS CITRIC ACID
- CALCIUM SULFATE
- CARRAGEENAN
- D&C RED NO. 33
- EDETATE DISODIUM
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- POLYSORBATE 80
- WATER
- SODIUM BENZOATE
- SORBITOL
- SUCROSE
- SODIUM PHOSPHATE, TRIBASIC
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11822-1023 | 11822-1023-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 25c3a73a-6dcb-44c0-8926-08d672314d7d | 768d37fc-bf3e-4e66-a7d1-8a068bcef3bf | 2024-07-24 | Warnings | 768d37fc-bf3e-4e66-a7d1-8a068bcef3bf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.