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NDC 69842-0820-08 Multi Symptom Cold and Multi Symptom Nighttime Cold Details
Multi Symptom Cold and Multi Symptom Nighttime Cold
Multi Symptom Cold and Multi Symptom Nighttime Cold is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. The primary component is .
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: 69842-0820-08Last Updated: 12/01/2022
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: 69842-0820-08Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 69842-0820-08Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
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: 69842-0820-08Last Updated: 12/01/2022
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: 69842-0820-08Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 69842-0820 |
|---|---|
| Product ID | 69842-820_3a14690c-cb44-4546-8fab-3ef6f892a773 |
| 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 | Multi Symptom Cold and Multi Symptom Nighttime Cold |
| Proprietary Name Suffix | Childrens |
| Non-Proprietary Name | Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI, Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | KIT |
| Route | n/a |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | CVS Pharmacy |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | n/a |
Package
Package Images
NDC 69842-0820-08 (69842082008)
| NDC Package Code | 69842-820-08 |
|---|---|
| Billing NDC | 69842082008 |
| Package | 1 KIT in 1 KIT (69842-820-08) * 118 mL in 1 BOTTLE, PLASTIC (69842-607-04) * 118 mL in 1 BOTTLE, PLASTIC (69842-606-04) |
| Marketing Start Date | 2017-02-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e Details
Active ingredients for Nighttime (in each 10 mL)
Active ingredients for Daytime (in each 5 mL)
Purpose for Nighttime
Uses
Nighttime
- temporarily relieves these common cold and flu symptoms
- minor aches and pains
- headache
- sore throat
- sneezing
- runny nose
- nasal congestion
- cough
- controls cough to help your child get to sleep
- temporarily reduces fever
Daytime
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive
- temporarialy relieves
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- nasal congestion due to a cold
- stuffy nose
Warnings
NIGHTTIME
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
Nighttime
- 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 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
- with any other drug containing diphenhydramine, even one used on skin.
- If your child is allergic to acetaminophen or any of the inactive ingredients in this product
- to make a child sleepy
Daytime
- in a child who is taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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 you have
Nighttime
- liver disease
- heart disease
- thyroid disease
- diabetes
- glaucoma
- high blood pressure
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
Daytime
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- 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 you are
Nighttime
- taking the blood thinning drug warfain
- taking sedative or tranquilizers
When using these products
Nighttime
- do not use more than directed
- marked drowsiness may occur
- excitablity may occur, especially in children
- sedatives and tranquilizer may increase drowsiness
Daytime
- do not use more than directed
Stop use and ask a doctor if
Nighttime
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or last more than 5 days
- redness or swelling is present
- new symptoms occurs
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious conditions.
Daytime
- nervousness, dizziness or sleeplessness occur
- symptoms do not better within 7 days or occur with fever
- cough lasts more than 7 days, comes back or occur with a fever, rash, or headache that lasts. These could be signs of a serious condition.
Keep out of reach of children.
Nighttime
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 (1-800-222-1222). Quick medical attention is critical even if you do not notice any sign or symptoms.
Daytime
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Nighttime
- 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
- measure only with dosing cup provided. Do not use any other dosing device.
- mL = milliliter
- dose as follows or as directed by a doctor
- children 6 to under 12 years of age: 10 mL every 4 hours
- children under 6 years of age: do not use
Daytime
- do not take more than 6 doses in any 24-hours period
- use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device
- keep dosing cup with product
- dose as follows, or as directed by a doctor
- mL = milliliter
| Age | Dose |
| children 6 years to under 12 years | 10 mL every 4 hours |
| children 4 years to under 6 years | 5 mL every 4 hours |
| children under 4 years | do not use |
Other information
Inactive ingredients
Nighttime
citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Daytime
citric acid, disodium EDTA, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose xanthan gum
Principal Display Panel
Compare to the active ingredients in Children's Mucinex® Night Time Multi-Symptom Cold**
Children's
multi-symptom
Nighttime Cold
ACETAMINOPHEN 325 mg (pain reliever / fever reducer)
DIPHENHYDRAMINE HCI 12.5 mg (Antihistamine-Cough Suppressant)
PHENYLEPHRINE HCI 5 mg (Nasal Decongestant)
Relieves:
Nasal and chest congestion
Reduces fever
Soothes cough and sore throat
Berry Flavor Liquid
Dosage Cup Included
Ages 6 - 11 Years
FL OZ (mL)
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
**This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Night Multi-Symptom Time Cold
DAYTIME
Compare to active ingredients in Children's Mucinex® Multi-Symptom Cold*
Children's
multi-symptom cold
DEXTROMETHORPHAN HBr 5 mg (Cough Suppressant)
GUAIFENESIN 100 mg (expectorant)
PHENYLEPHRINE HCI 2.5 mg (Nasal Decongestant)
Relieves:
Nasal and chest congestion
Soothes cough
Thins and loosens mucus
Berry Flavor Liquid
Dosage cup included
Ages 4 to 11 years
FL OZ (mL)
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
1-800-SHOP CVS
INGREDIENTS AND APPEARANCE
| MULTI SYMPTOM COLD AND MULTI SYMPTOM NIGHTTIME COLD
CHILDRENS
dextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci kit |
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| Labeler - CVS Pharmacy (062312574) |