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NDC 49035-0772-03 Childrens Multi-symptom Cold and Fever Liquid 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL Details
Childrens Multi-symptom Cold and Fever Liquid 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL
Childrens Multi-symptom Cold and Fever Liquid is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores, Inc.. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 49035-0772-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 49035-0772-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 49035-0772-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 49035-0772-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
NDC | 49035-0772 |
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Product ID | 49035-772_7bf30c75-e867-4a2f-a481-702d7aa96c23 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Childrens Multi-symptom Cold and Fever Liquid |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl |
Product Type | HUMAN OTC DRUG |
Dosage Form | LIQUID |
Route | ORAL |
Active Ingredient Strength | 325; 10; 200; 5 |
Active Ingredient Units | mg/10mL; mg/10mL; mg/10mL; mg/10mL |
Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
Labeler Name | Wal-Mart Stores, Inc. |
Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part341 |
Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 49035-0772-03 (49035077203)
NDC Package Code | 49035-772-03 |
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Billing NDC | 49035077203 |
Package | 1 BOTTLE in 1 CARTON (49035-772-03) / 118 mL in 1 BOTTLE |
Marketing Start Date | 2017-08-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7bf30c75-e867-4a2f-a481-702d7aa96c23 Details
ACTIVE INGREDIENTS (in each 10 mL)
USE(S)
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
WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
- more than 5 doses in 24 hous, 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.
- 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.
ASK A DOCTOR BEFORE USE IF THE CHILD HAS
STOP USE AND ASK 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
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 use
- do not give 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.
- mL = milliliter
- Children under 6 years of age: do not use.
OTHER INFORMATION
INACTIVE INGREDIENTS
PRINCIPAL DISPLAY PANEL
NDC 49035-772-03
equate
Compare to Children's Mucinex®Multi-Symptom Cold & Fever active ingredients*
Children's Multi-Symptom Cold & Fever Liquid
Acetaminophen 325 mg
Pain reliever/Fever Reducer
Dextromethorphan HBr 10 mg
Cough Suppressant
Guaifenesin 200 mg
Expectorant
Phenylephrine HCl 5 mg
Nasal Decongestant
AGES 6 to 12 YEARS
- Relieves nasal and chest congestion
- Soothes Cough
- Reduces fever
- Thins and loosens Mucus
- Alcohol Free
- Berry Burst Flavored
4 FL OZ (118 mL)
INGREDIENTS AND APPEARANCE
CHILDRENS MULTI-SYMPTOM COLD AND FEVER LIQUID
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid |
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Labeler - Wal-Mart Stores, Inc. (051957769) |