Indications and uses
temporarily relieves the following cold/flu symptoms: minor aches and pains sneezing and runny nose sore throat headache cough stuffy nose temporarily reduces fever
Multi Symptom Cold
- Manufacturer
- QUALITY CHOICE (Chain Drug Marketing Association)
- Effective date
- 2019-09-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:13:33
Label at a glance#
ProductMulti Symptom Cold Childrens Plus
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
this product does not contain directions or complete warnings for adult use mL = milliliter shake well before using measure only with dosing cup provided do not use any other dosing device keep dosing cup with product do not give more than 5 times in 24 hours if needed, repeat dose every 4 hours while symptoms last find the right dose on chart below. If possible, use weight to dose; otherwise, use age. Weight (...
Contacts and useful links#
Websitewww.qualitychoice.com
www.qualitychoice.com
www.qualitychoice.comLabel 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
Purposes
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- sneezing and runny nose
- sore throat
- headache
- cough
- stuffy nose
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occurif 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
- 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.
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if the child has
- liver disease
- heart disease
- glaucoma
- thyroid disease
- diabetes
- high blood pressure
- a breathing problem such as chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
Ask a doctor or pharmacist before use if the child is taking
- sedatives or tranquilizers
- the blood thinning drug warfarin
When using this product
- do not exceed recommended dose (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
- new symptoms occur
- redness or swelling is present
- pain, nasal congestion or cough gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- nervousness, dizziness or sleeplessness occurs
- 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
- mL = milliliter
- shake well before using
- measure only with dosing cup provided
- do not use any other dosing device
- keep dosing cup with product
- do not give more than 5 times in 24 hours
- if needed, repeat dose every 4 hours while symptoms last
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
| Weight (lb) | Age (yr) | Dose ( mL) |
| 48-95 | 6-11 | 10 mL |
| 36-47 | 4-5 | do not use unless directed by a doctor |
| under 36 | under 4 | do not use |
Other Information
- store at 20-25ºC (68-77ºF)
- do not refrigerate
Inactive ingredients
anhydrous citric acid carboxymethylcellulose sodium, D&C red 33, FD&C blue 1, FD&C red 40, flavors, glycerin, microcrystalline cellulose purified water, sodium benzoate, sorbitol, sucrose, xanthan gum
Questions or comments?
Call 1-248-449-9300 Monday-Friday 9AM-5PM EST
Principal Display Panel
*Compare to the active ingredients in Children's Tylenol® Plus Multi-Symptom Cold
Children's Multi-Symptom Cold Plus
Oral Suspension
Acetaminophen 160 mg Fever & Sore Throat
Chlorpheniramine Maleate 1 mg Runny Nose & Sneezing
Dextromethorphan HBr 5 mg Cough
Phenylephrine HCI 2.5 mg Stuffy Nose
For Ages 6-11
Grape Flavor
FL OZ (mL)
dosage cup included
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Plus Multi-Symptom Cold.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
Question: 248-449-9300
Package Label
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| CHLORPHENIRAMINE MALEATE | ACTIVE INGREDIENT | V1Q0O9OJ9Z | 1 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| CHLORPHENIRAMINE | ACTIVE MOIETY | 3U6IO1965U | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | INACTIVE INGREDIENT | K679OBS311 | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Multi Symptom Cold Childrens Plus
- Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
- ACETAMINOPHEN
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- CARBOXYMETHYLCELLULOSE SODIUM
- CELLULOSE, MICROCRYSTALLINE
- ANHYDROUS CITRIC ACID
- D&C RED NO. 33
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- WATER
- SODIUM BENZOATE
- SORBITOL
- SUCROSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63868-962 | 63868-962-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SUSPENSION / ORAL | 1080 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / SUBLINGUAL | 50.5 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / ORAL | 400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SPONGE / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION / INTRAMUSCULAR | 30 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SOLUTION / ORAL | 2 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FOR SUSPENSION / ORAL | 20100 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CONCENTRATE / ORAL | 84 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SHAMPOO / TOPICAL | NA | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | LOZENGE / ORAL | 1264 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / RECTAL | 46.18 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / TOPICAL | 0.11 %w/v | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CLOTH / TOPICAL | 4.2 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | MOUTHWASH / BUCCAL | NA | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SYRUP / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION / INTRAMUSCULAR | 864 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | FILM / BUCCAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 6 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| SORBITOL | SORBITOL | 506T60A25R | AEROSOL, FOAM / TOPICAL | 4.95 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / OPHTHALMIC | 2 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SOLUTION / ORAL | 3480 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | FILM, SOLUBLE / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / TOPICAL | 0.01 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SHAMPOO / TOPICAL | 2 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, SOLUTION / SUBCUTANEOUS | 4.7 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v |
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 |
|---|---|---|---|---|---|---|
| d91f3b97-2c10-4f03-9b21-d139cbd0e5a3 | 2d03f97b-2eb6-4903-9cef-b6d6c016e90b | 2019-09-03 | Warnings | d91f3b97-2c10-4f03-9b21-d139cbd0e5a3 2d03f97b-2eb6-4903-9cef-b6d6c016e90b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.