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NDC 69842-0737-02 cooling severe daytime cooling severe nighttime Details
cooling severe daytime cooling severe nighttime
cooling severe daytime cooling severe nighttime is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. The primary component is .
Product Information
| NDC | 69842-0737 |
|---|---|
| Product ID | 69842-737_a7d5d483-8562-4633-a497-5f4467d0cb48 |
| 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 | cooling severe daytime cooling severe nighttime |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride,Guaifenesin |
| 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 | 2024-12-31 |
Package
Package Images
NDC 69842-0737-02 (69842073702)
| NDC Package Code | 69842-737-02 |
|---|---|
| Billing NDC | 69842073702 |
| Package | 1 KIT in 1 PACKAGE (69842-737-02) * 355 mL in 1 BOTTLE (69842-182-40) * 355 mL in 1 BOTTLE (69842-590-40) |
| Marketing Start Date | 2019-07-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL cd1c7a50-790d-41de-a4ec-34e3071f77a7 Details
Active ingredients (in each 30 mL) – Night Time
Uses
temporarily relieves common cold/flu symptoms:
- •
- nasal congestion
- •
- sinus congestion and pressure
- •
- minor aches and pains
- •
- headache
- •
- sore throat
- •
- runny nose and sneezing
- •
- cough to help you sleep
- •
- cough due to minor throat and bronchial irritation
- •
- reduces swelling of nasal passages
- •
- fever
- •
- promotes nasal and/or sinus drainage
- •
- temporarily restores freer breathing through the nose
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- •
- more than 4,000 mg of acetaminophen in 24 hours
- •
- with other drugs containing acetaminophen
- •
- 3 or more alcoholic drinks every day while using this product
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.
- •
- if you are now 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 you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- •
- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- glaucoma
- •
- cough that occurs with too much phlegm (mucus)
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- trouble urinating due to an enlarged prostate gland
- •
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- •
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
- •
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- •
- you get nervous, dizzy or sleepless
- •
- 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
Inactive ingredients
Active ingredients (in each 30 mL) - Day Time
Uses
temporarily relieves common cold/flu symptoms:
- •
- nasal congestion
- •
- sinus congestion and pressure
- •
- cough due to minor throat and bronchial irritation
- •
- minor aches and pains
- •
- headache
- •
- fever
- •
- reduces swelling of nasal passages
- •
- temporarily restores freer breathing through the nose
- •
- sore throat
- •
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- •
- promotes nasal and/or sinus drainage
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- •
- more than 4,000 mg of acetaminophen in 24 hours
- •
- with other drugs containing acetaminophen
- •
- 3 or more alcoholic drinks every day while using this product
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.
- •
- if you are now 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 you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- •
- liver disease
- •
- heart disease
- •
- thyroid disease
- •
- high blood pressure
- •
- trouble urinating due to an enlarged prostate gland
- •
- cough that occurs with too much phlegm (mucus)
- •
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- •
- diabetes
- •
- a sodium-restricted diet
Stop use and ask a doctor if
- •
- you get nervous, dizzy or sleepless
- •
- pain, nasal congestion, or cough gets worse or lasts more than 7 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
Other information
Inactive ingredients
Package/Label Principal Display Panel
Compare to the active ingredients in Vicks® DayQuil® Severe+VapoCOOL™
Cooling
Severe Daytime
COLD & FLU RELIEF
ACETAMINOPHEN – Pain reliever/Fever reducer
PHENYLEPHRINE HCl – Nasal decongestant
DEXTROMETHORPHAN HBr – Cough suppressant
GUAIFENESIN – Expectorant
Relieves:
Minor aches, pains & fever
Nasal congestion & sinus pressure
Cough
Chest congestion
ALCOHOL 10%
12 FL OZ (355 mL)
Compare to the active ingredients in Vicks® NyQuil® Severe+VapoCOOL™
Cooling
Severe Nighttime
COLD & FLU RELIEF
ACETAMINOPHEN – Pain reliever/Fever reducer
PHENYLEPHRINE HCl – Nasal decongestant
DOXYLAMINE SUCCINATE - Antihistamine
DEXTROMETHORPHAN HBr – Cough suppressant
Relieves:
Minor aches, pains & fever
Nasal congestion & sinus pressure
Sneezing, runny nose
Cough
ALCOHOL 10%
12 FL OZ (355 mL)
INGREDIENTS AND APPEARANCE
| COOLING SEVERE DAYTIME COOLING SEVERE NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride,guaifenesin kit |
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| Labeler - CVS Pharmacy (062312574) |
Revised: 1/2020
Document Id: a7d5d483-8562-4633-a497-5f4467d0cb48
Set id: cd1c7a50-790d-41de-a4ec-34e3071f77a7
Version: 3
Effective Time: 20200102