FDA Label for Daytime Nighttime Cold Flu Relief
View Indications, Usage & Precautions
Daytime Nighttime Cold Flu Relief Product Label
The following document was submitted to the FDA by the labeler of this product Apnar Pharma Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients for Daytime (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Active ingredients for Nighttime (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Otc - Purpose
Purposes
for Daytime
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Purposes
for Nighttime
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Indications & Usage
Uses
Daytime
- temporarily relieves common cold and flu symptoms
- cough due to minor throat and bronchial irritation
- nasal congestion
- headache
- minor aches and pains
- Fever
- sore throat
- temporarily relieves common cold and flu symptoms
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing
Uses
Nighttime
Warnings
Warnings
Daytime
Liver warning: These products contain 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 products
- skin reddening
- blisters
- rash
- 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 products
- skin reddening
- blisters
- rash
- 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.
- 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.
- liver disease
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- trouble urinating due to an enlarged prostate gland
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- do not exceed recommended dosage
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- nervousness, dizziness or sleeplessness occur
- pain, cough, and nasal congestion gets worse or lasts more than 7 days
- redness or swelling is present
- new symptoms occur
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with rash or headache that lasts
- 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 headache that lasts.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
Nighttime
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
Daytime
Nighttime
Ask a doctor before use if you have
Daytime
Nighttime
Ask a doctor or pharmacist before use if you are
Daytime
taking the blood thinning drug warfarin
Nighttime
When using this product
Daytime
do not exceed recommended dosage
Nighttime
Stop use and ask a doctor if
Daytime
These could be signs of a serious condition.
Nighttime
These could be a signs of a serious condition
If pregnant or breast-feeding,
ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
Overdose warning:
Taking more than the recommended dose can 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 for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions
Daytime
- do not take more than directed (see Overdose warning)
- do not take more than 4 doses in 24 hours
- swallow whole; do not crush, chew, or dissolve
- do not take more than directed (see Overdose warning)
- do not take more than 4 doses in 24 hours
- swallow whole; do not crush, chew, or dissolve
adults and children 12 years and over: take 2 softgels with water every 4 hours.
children under 12 years: do not use
Nighttime
adults and children 12 years and over: take 2 softgels with water every 6 hours
children under 12 years: do not use
Storage And Handling
Other information
- store between 15-30°C (59-86°F)
- avoid excessive heat
Inactive Ingredient
Inactive ingredients
Daytime
Gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, FD&C yellow #6, FD&C Red #40 , white ink
Nighttime
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink
Otc - Questions
Questions or comments?
Call 1-855-642-2594
Package Label.Principal Display Panel
†Compare to the active ingredients in Vicks® DayQuil® and NyQuil® Cold & Flu LiquiCaps®
Daytime
NDC 24689-152-01
Multi-Symptom Cold & Flu Relief
Acetaminophen 325 mg- Pain reliever / Fever reducer
Dextromethorphan HBr 10 mg - Cough suppressant
Phenylephrine HCI 5 mg - Nasal decongestant
Relieves:
- Aches, fever, sore throat
- Cough
- Nasal congestion
- Aches, fever, sore throat
- Cough
- Runny nose, sneezing
Non-drowsy
Alcohol-Free
Antihistamine-Free
Softgels**
(** Liquid-filled capsules)
Nighttime
Multi-Symptom Cold & Flu Relief
Acetaminophen 325 mg - Pain reliever / Fever reducer
Dextromethorphan HBr 15 mg - Cough suppressant
Doxylamine succinate 6.25 mg - Antihistamine
Relieves:
Softgels**
Alcohol-free
(**Liquid-filled capsules)
When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing.
†This product is not manufactured or distributed by The Procter & Gamble Company.
Vicks®, DayQuil®, NyQuil®, and LiquiCaps® are registered trademarks of the Procter and Gamble Company.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Distributed by:
APNAR PHARMA LP
CHINO, CA, USA, 91710
Rev.: 04/2023
* Please review the disclaimer below.