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NDC 00113-0567-02 Good Sense NightTime DayTime Cold and Flu Details
Good Sense NightTime DayTime Cold and Flu
Good Sense NightTime DayTime Cold and Flu is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by L. Perrigo Company. 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: 00113-0567-02Last 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: 00113-0567-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine 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: 00113-0567-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine
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: 00113-0567-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00113-0567 |
|---|---|
| Product ID | 0113-0567_6c169871-e364-406d-800d-2a034c091ad4 |
| 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 | Good Sense NightTime DayTime Cold and Flu |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl |
| 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 | L. Perrigo Company |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 00113-0567-02 (00113056702)
| NDC Package Code | 0113-0567-02 |
|---|---|
| Billing NDC | 00113056702 |
| Package | 1 KIT in 1 KIT (0113-0567-02) * 354 mL in 1 BOTTLE * 354 mL in 1 BOTTLE |
| Marketing Start Date | 2014-01-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 54d894ff-2db5-4a85-8477-53dffbcd5981 Details
Nighttime Cold & Flu Active Ingredients (in each 30 mL)
Uses
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
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
Keep out of reach of children.
Directions - Nighttime
Inactive ingredients
Daytime Cold & FluActive ingredients (in each 15 mL)
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- •
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- •
- child takes more than 5 doses in 24 hours
- •
- taken with other drugs containing acetaminophen
- •
- adult has 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
Stop use and ask a doctor if
- •
- you get nervous, dizzy or sleepless
- •
- pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- •
- 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
Package/Label Principal Display Panel
Multi-Symptom Relief
Non-Drowsy
See New Warnings
Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant
DayTime
Cold & Flu
Acetaminophen
Phenylephrine HCl
Dextromethorphan HBr
Aches
Fever
Cough
Sore Throat
Nasal Congestion
Compare to active ingredients of Vicks® DayQuil® Cold & Flu
12 FL OZ (354 mL)
Alcohol Free
Powerful
Non-Drowsy Relief
Multi-Symptom Relief
See New Warnings
Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine
NightTime
Cold & Flu
Acetaminophen
Dextromethorphan HBr
Doxylamine Succinate
Aches
Fever
Cough
Sore Throat
Sneezing - Runny Nose
Original Flavor
Compare to active ingredients of Vicks® NyQuil® Cold & Flu
12 FL OZ (354 mL)
ALCOHOL 10%
INGREDIENTS AND APPEARANCE
| GOOD SENSE NIGHTTIME DAYTIME COLD AND FLU
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit |
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| Labeler - L. Perrigo Company (006013346) |