FDA Label for Cold And Flu Multi-symptom Relief/cold And Flu Nighttime Relief
View Indications, Usage & Precautions
- DRUG FACTS - DAY TIME
- DRUG FACTS - NIGHT TIME
- PURPOSE - DAY TIME
- PURPOSE - NIGHT TIME
- USES - DAY TIME
- USES - NIGHT TIME
- WARNINGS - DAY TIME
- WARNINGS - NIGHT TIME
- DO NOT USE - DAY TIME
- DO NOT USE - NIGHT TIME
- ASK A DOCTOR BEFORE USE IF YOU HAVE - DAY TIME
- ASK A DOCTOR BEFORE USE IF YOU HAVE - NIGHT TIME
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE - DAY TIME
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE - NIGHT TIME
- WHEN USING THIS PRODUCT,
- WHEN USING THIS PRODUCT - NIGHT TIME
- STOP USE AND ASK A DOCTOR IF - DAY TIME
- STOP USE AND ASK A DOCTOR IF - NIGHT TIME
- IF PREGNANT OR BREAST-FEEDING,
- IF PREGNANT OR BREAST-FEEDING, - NIGHT TIME
- KEEP OUT OF REACH OF CHILDREN. - DAY TIME
- KEEP OUT OF REACH OF CHILDREN. - NIGHT TIME
- DIRECTIONS - DAY TIME
- DIRECTIONS - NIGHT TIME
- OTHER INFORMATION - DAY TIME
- OTHER INFORMATION - NIGHT TIME
- INACTIVE INGREDIENTS - DAY TIME
- INACTIVE INGREDIENTS - NIGHT TIME
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 16 FL OZ (474 ML BOTTLE)
Cold And Flu Multi-symptom Relief/cold And Flu Nighttime Relief Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, Llc. 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.
Drug Facts - Day Time
Active ingredients (in each capsule)
Acetaminophen USP 325 mg
Dextromethorphan HBr USP 10 mg
Phenylephrine HCl USP 5 mg
Drug Facts - Night Time
Active ingredients (in each capsule)
Acetaminophen USP 325 mg
Dextromethorphan HBr USP 15 mg
Doxylamine succinate USP 6.25 mg
Purpose - Day Time
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Purpose - Night Time
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses - Day Time
temporarily relieves common cold/flu symptoms:
- nasal congestion
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
Uses - Night Time
temporarily relieves common cold/flu symptoms:
- nasal congestion
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
runny nose & sneezing
Warnings - Day Time
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
Warnings - Night Time
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
Do Not Use - Day Time
- 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.
Do Not Use - Night Time
- 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 Have - Day Time
liver disease
heart disease
thyroid disease
diabetes
high blood pressure
trouble urinating due to enlarged prostate gland
cough that occurs with too much phlegm (mucus)
persistent or chronic cough as occurs with smoking, asthma, or emphysema
Ask A Doctor Before Use If You Have - Night Time
- 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 You Are - Day Time
taking the blood thinning drug warfarin
Ask A Doctor Or Pharmacist Before Use If You Are - Night Time
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When Using This Product,
do not use more than directed.
When Using This Product - Night Time
- 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 - Day Time
you get nervous, dizzy or sleepless
symptoms get worse or last 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.
Stop Use And Ask A Doctor If - Night Time
- 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 Breast-Feeding,
ask a health professional before use.
If Pregnant Or Breast-Feeding, - Night Time
ask a health professional before use.
Keep Out Of Reach Of Children. - Day Time
Overdose warning:
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
Keep Out Of Reach Of Children. - Night Time
Overdose warning:
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
Directions - Day Time
- take only as directed – see Overdose warning
- do not exceed 4 doses per 24 hours
| adults & children 12 yrs & over | 2 capsules with water every 4 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
Directions - Night Time
- take only as directed – see Overdose warning
- do not exceed 4 doses per 24 hours
| adults & children 12 yrs & over | 2 capsules with water every 6 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
Other Information - Day Time
- store at room temperature
Other Information - Night Time
- store at room temperature
Inactive Ingredients - Day Time
citric acid anhydrous, gelatin, glycerin, Neelicert FD & C Red No. 40, Neelicert FD & C Yellow No. 6, noncrystallizing sorbitol solution, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, titanium dioxide
Inactive Ingredients - Night Time
D&C Yellow No. 10, gelatin, glycerin, Neelicert FD&C Blue No. 1, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitol sorbitan solution, titanium dioxide
Questions Or Comments?
call 1-855-274-4122
Distributed by:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, Pa 19087
Package Label-Principal Display Panel 16 Fl Oz (474 Ml Bottle)
NDC 68016-879-18
Premier Value®
COMPARE TO THE ACTIVE INGREDIENTS IN
VICKS® DAYQUIL® AND VICKS® Nyquil® COLD &
FLU MULTI-SYMPTOM RELIEF LIQUICAPS®
Non-Drowsy Multi-Symptom
Daytime Nighttime
COLD & FLU RELIEF
Acetaminophen, Acetaminophen,
Dextromethorphan HBr and Dextromethorphan HBr,
Phenylephrine HCl Capsules Doxylamine Succinate Capsules
325 mg/10 mg/5 mg 325 mg/15 mg/6.25 mg
• Aches, Fever & Sore Throat • Aches, Fever & Sore Throat
• Nasal Congestion • Sneezing, Runny Nose
• Cough • Cough
32 Capsules 16 Capsules
* Please review the disclaimer below.