Indications and uses
temporarily relieves the following cold/flu symptoms: minor aches and pains sore throat stuffy nose sneezing and runny nose headache temporarily reduces fever
Childrens Plus Cold
- Manufacturer
- QUALITY CHOICE (Chain Drug Marketing Association)
- Effective date
- 2018-12-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:39:26
Label at a glance#
ProductChildrens Plus Cold
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, 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 (lb) ...
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
Phenylephrine HCI 2.5 mg
Purposes
Pain reliever/fever reducer
Antihistamine
Nasal decongestant
Uses
- temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- sore throat
- stuffy nose
- sneezing and runny nose
- headache
- temporarily reduces fever
Warnings
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
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 contaning acetaminophen
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 drug containing acetaminophen (prescription or non prescription). 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 is allergic to acetaminophen or any of the inactive ingredients in this product.
Ask a doctor before use if the child has
- liver disease
- diabetes
- glaucoma
- thyroid
- heart disease
- high blood pressure
- a breathing problem such as chronic bronchitis
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 get worse or lasts more than 5 days
- fever gets worse or last more than 3 days
- nervousness, dizziness or sleeplessness occurs
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(68-77F)
- do not refrigerate
Inactive ingredients
anhydrous citric acid, carboxymethylcellulose sodium, D&C red #33, FD&C blue #1, FD&C red 40, flavors, glycerin, microrocrystalline 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 Cold
Children's Cold Plus
Oral Suspension
Acetaminophen 160mg Fever & Sore Throat
Chlorpheniramine maleate 1mg Runny Nose & Sneezing
Phenylephrine HCI 2.5mg Stuffy Nosse
For ages 6 to 11
Grape Flavor
FL OZ (mL)
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Plus 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
Package Label
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| CHLORPHENIRAMINE MALEATE | ACTIVE INGREDIENT | V1Q0O9OJ9Z | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| CHLORPHENIRAMINE | ACTIVE MOIETY | 3U6IO1965U | 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.
- Childrens Plus Cold
- Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCI
- ACETAMINOPHEN
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- CELLULOSE, MICROCRYSTALLINE
- ANHYDROUS CITRIC ACID
- GLYCERIN
- WATER
- D&C RED NO. 33
- FD&C RED NO. 40
- SODIUM BENZOATE
- SORBITOL
- XANTHAN GUM
- CARBOXYMETHYLCELLULOSE SODIUM
- FD&C BLUE NO. 1
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63868-036 | 63868-036-04 |
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 |
|---|---|---|---|---|---|---|
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | OIL / TOPICAL | 2 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, EXTENDED RELEASE / ORAL | 933 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / SUBLINGUAL | 50.5 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET / BUCCAL | 4 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, ORALLY DISINTEGRATING / ORAL | 46 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SUSPENSION/ DROPS / ORAL | 12.85 mg/2.5ml | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SUSPENSION / ORAL | 0.13 mg/5ml | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | CAPSULE, LIQUID FILLED / ORAL | 0.01 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | PASTE, DENTIFRICE / DENTAL | 1.2 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / OPHTHALMIC | 6 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | PELLET / ORAL | 1140 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CREAM / TOPICAL | 0.2 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, DELAYED RELEASE / ORAL | 0.34 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | AEROSOL, FOAM / TOPICAL | 4.95 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 2350 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / SUBLINGUAL | 36 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | GEL / DENTAL | 0.4 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.6 %w/w | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SOLUTION / TOPICAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / ORAL | 400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | ELIXIR / ORAL | 5.02 mg/5ml | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 5 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 48 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAMUSCULAR | NA | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION / ORAL | 450 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SYSTEM / TOPICAL | 1680 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SUSPENSION / ORAL | 1080 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE, FOR SUSPENSION / ORAL | 120 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | FILM, SOLUBLE / ORAL | 1 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SHAMPOO / TOPICAL | 0.75 %w/w |
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 |
|---|---|---|---|---|---|---|
| 792ba8f6-9b15-4e61-a80f-052619c28eac | ab384d3d-fb33-4aec-9393-822b199e58b6 | 2018-12-26 | Warnings | 792ba8f6-9b15-4e61-a80f-052619c28eac ab384d3d-fb33-4aec-9393-822b199e58b6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.