![CHILDRENS PLUS MULTI SYMPTOM COLD DYE FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]](https://medic.hrt.org//dailymed/images/d75b1024-2d58-4fbb-b3e8-1d62ff3ed00f/childrens-plus-multi-symptom-cold-dye-free-grape-d-1.jpg)
| NDC | 55910-303-04 |
| Set ID | d75b1024-2d58-4fbb-b3e8-1d62ff3ed00f |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 5 mL)
- Purpose
- Uses
-
Warnings
Liver warning: This product contain acetaminophen. Severe liver damage may occur if your child take:
- more than 5 doses (10 mL) 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
- wth 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking 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
- glaucoma
- thyroid disease
- diabetes
- heart disease
- 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 last more than 5 days
- fever gets worse or last 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 for adults as well as children 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
- do not give more than 5 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- 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
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Children's Plus Multi-Symptom Cold
ORAL SUSPENSION
Relief of
- Fever & sore throat ACETAMINOPHEN
- Sneezing & runny nose CHLORPHENIRAMINE MALEATE
- Cough DEXTROMETHORPHAN HBr
- Stuffy nose PHENYLEPHRINE HCI
FOR AGES 6-11 YEARS
DYE Free
Grape Flavor
Dosing Cup Included
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
PACKAGED FOR DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072 USA
Visit us at: Rexall.com
- Package Label
-
INGREDIENTS AND APPEARANCE
CHILDRENS PLUS MULTI SYMPTOM COLD DYE FREE
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-303 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 1 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-303-04 1 in 1 BOX 07/31/2015 01/05/2024 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/31/2015 01/05/2024 Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)
