![CHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]](https://medic.hrt.org//dailymed/images/78209395-d854-477e-b097-89a5227638e6/WC622.jpg)
| NDC | 67091-221-18 |
| Set ID | 78209395-d854-477e-b097-89a5227638e6 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | WinCo Foods, LLC |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 10 mL)
- Purpose
- KEEP OUT OF REACH OF CHILDREN
-
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- stuffy nose
- cough due to minor throat and bronchial irritation
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- minor aches and pains
- sore throat
- headache
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
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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 maximum daily amount
- with other drugs containing acetaminophen
- Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, vomiting, consult a doctor promptly.
Do not use
- 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.
- 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 giving this product.
Ask a doctor before use if the child has
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if
you are taking the blood thinning drug warfarin
When using this product
- do not use more than directed
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. 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 right away. Quick medical attention is critical for adults as well as for children 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 take more than directed (see overdose warning)
- shake well before use
- do not take more than 5 doses in any 24 hour period
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 days unless directed by a doctor
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- Children 6 to under 12 years of age: 10 mL in dosing cup provided
- Children under 6 years of age: do not use
- Other information
- Inactive ingredients
- Questions?
-
PDP
*Compare to the active ingredients in Childrens MUCINEX® Multi-symptom Cold and Fever
Childrens Multi-Symptom Cold and Fever Relief
ACETAMINOPHEN 325 mg per 10 mL /PAIN RELIEVER-FEVER REDUCER
DEXTROMETHORPHAN HBr /COUGH SUPPRESSANT
GUAIFENESIN /EXPECTORANT
PHENYLEPHRINE HCl /NASAL DECONGESTANT
Relieves: Cough, Nasal & Chest Congestion
Thins & Loosens Mucus
Reduces fever
For Ages 6-12 Years
Berry Burst Flavor
4 FL OZ (118 mL)
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INGREDIENTS AND APPEARANCE
CHILDRENS MULTI-SYMPTOM COLD AND FEVER RELIEF
acteaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-221 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color blue Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67091-221-18 1 in 1 CARTON 12/12/2014 1 118 mL in 1 BOTTLE; 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 12/12/2014 Labeler - WinCo Foods, LLC (056098817)