Active Ingredient(S)
DAYTIME ONLY
Acetaminophen 325mg
Dextromethorphan HBr 10mg
NIGHTTIME ONLY
Acetaminophen 325mg
Dextromethorphan HBr 15mg
Doxylamine succinate 6.25mg
Daytime And Nighttime Cold And Flu Kit
FDA Label NDC 69168-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Daytime And Nighttime Cold And Flu Kit (NDC 69168-013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use if you have, ask a doctor before use if you, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
DAYTIME ONLY
Pain reliever/fever reducer
Cough suppressant
NIGHTTIME ONLY
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Use(S)
DAYTIME ONLY
temporarily relieves these symptoms due to a cold or flu:
- cough
- sore throat
- headache
- minor aches and pains
- temporarily reduces fever
NIGHTTIME ONLY
temporarily relieves common cold/flu symptoms:
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever
• runny nose & sneezing
Warnings
DAYTIME
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 10 softgels in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
NIGHTTIME
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 4 doses in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
DAYTIME AND NIGHTTIME
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,
occurs with or is followed by fever, headache, rash, nausea, or vomiting,
consult a doctor promptly.
Do Not Use If You Have
DAYTIME ONLY
• 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
- in children under 12 years of age
NIGHTTIME ONLY
• 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.
• to make a child sleep
Ask A Doctor Before Use If You
DAYTIME ONLY
• liver disease • heart disease • thyroid disease • diabetes • high blood pressure
• trouble urinating due to an enlarged prostate gland • cough that occurs
with too much phlegm (mucus) • persistent or chronic cough as occurs
with smoking, asthma, or emphysema
NIGHTTIME ONLY
• liver disease •glaucoma • cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking,
asthma, chronic bronchitis or emphysema
• trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If
DAYTIME ONLY
taking the blood thinning drug warfarin.
NIGHTTIME ONLY
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin
When Using This Product
DAYTIME ONLY
do not exceed recommended dosage.
NIGHTTIME ONLY
• do not use more than directed
• excitability may occur, especially in children
• marked drowsiness may occur • avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives & tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
DAYTIME ONLY
Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occurs
- pain, cough gets worse or last 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.
NIGHTTIME ONLY
• pain 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.
If Pregnant Or Breastfeeding,
ask a health professional before use.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center
(1-800-222-1222) right away. Quick medical attention is critical
for adults as well as for children, even if you do not notice any signs or symptoms.
Directions
DAYTIME ONLY
- Take only as directed
- Do not exceed 4 doses in 24hours
- Take only as directed
- Do not exceed 4 doses in 24hours
Adults and children 12 yrs & over: 2 softgels with water every 4 hrs
Children under 12 yrs: ask a doctor
Children under 4 yrs: do not use
NIGHTTIME ONLY
Adults and children 12 yrs & over: 2 softgels with water every 6 hrs
Children 4 to under 12 yrs: ask a doctor
Children under 4 yrs: do not use
Other Information
- store at room temperature 20-25 °C (68-77° F)
- Avoid excessive heat
- do not use if blister unit is torn or open
Inactive Ingredients
DAYTIME ONLY
FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K12, Propylene Glycol, Purified
water, Sorbitol Sorbitan Solution, White Edible Ink
NIGHTTIME ONLY
D&C Yellow #10, FD&C Blue #1, Gelatin, Glycerin, Polyethylene Glycol, Povidone, Propylene
Glycol, Purified Water, Sorbitol Sorbitan Solution, White Edible Ink
Questions/Comments
Call 1-888-952-0050
(Monday-Friday 9 AM – 5 PM EST)
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Daytime and Nighttime Cold and Flu
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