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NDC 00363-4050-04 Cough Cold and Sore Throat 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL Details
Cough Cold and Sore Throat 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL
Cough Cold and Sore Throat is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens. 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: 00363-4050-04Last 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: 00363-4050-04Last 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: 00363-4050-04Last 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: 00363-4050-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00363-4050 |
|---|---|
| Product ID | 0363-4050_c1b95f3b-e9e7-4c17-a09d-dedff0b80bfe |
| Associated GPIs | |
| GCN Sequence Number | 067928 |
| GCN Sequence Number Description | phenylephrine/DM/acetaminop/GG LIQUID 5-325MG/10 ORAL |
| HIC3 | B4P |
| HIC3 Description | NON-OPIOID ANTITUSS-DECONGESTANT-ANALGESIC-EXPECT |
| GCN | 30579 |
| HICL Sequence Number | 035445 |
| HICL Sequence Number Description | PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR/ACETAMINOPHEN/GUAIFEN |
| Brand/Generic | Generic |
| Proprietary Name | Cough Cold and Sore Throat |
| Proprietary Name Suffix | Childrens |
| 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 | Walgreens |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00363-4050-04 (00363405004)
| NDC Package Code | 0363-4050-04 |
|---|---|
| Billing NDC | 00363405004 |
| Package | 1 BOTTLE, PLASTIC in 1 BOX (0363-4050-04) / 118 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2014-10-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 400a0998-e276-4c8d-9b41-145b1b405fff Details
Active ingredients (in each 10 mL)
Uses
- temporarily relieves these common cold and flu symptoms:
- cough due to minor throat and bronchial irritation
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- nasal congestion
- stuffy nose
- sore throat
- minor aches and pains
- headache
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus 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 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
- with any other drug containing acetaminophen (prescription or monprescription). 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 your child has
- liver disease
- heart disease
- high blood pressure
- diabetes
- thyroid disease
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with asthma
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
- redness or swelling is present
- new symptoms occur
- fever gets worse or lasts more than 3 days
- cough comes back, or occurs with a 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
- do not give more than directed (see Overdose warning)
- 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
- keep dosing cup with product
- use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- dose as follows, or as directed by a doctor
- mL=milliliter
- 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
Principal Display Panel
Compare to the active ingredients in Children's Mucinex® Cold, Cough & Sore Throat††
Children's
Cold, Cough & Sore Throat
ACETAMINOPHEN 325 mg /
PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr 10 mg /
COUGH SUPPRESSANT
GUAIFENESIN 200 mg / EXPECTORANT
PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT
- Relief from cough, sore throat, stuffy nose & chest congestion
- Breaks up mucus
AGES 6 - 11 YEARS
FL OZ (mL)
Berry flavor
††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Cold, Cough & Sore Throat.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
INGREDIENTS AND APPEARANCE
| COUGH COLD AND SORE THROAT
CHILDRENS
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid |
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| Labeler - Walgreens (008965063) |