DAYTIME AND NIGHTTIME COLD/FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate
Pharmacy Value Alliance, LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Daytime and Nighttime Cold/Flu Relief Softgels
Active ingredients (in each Softgel) (DAYTIME ONLY)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Active ingredients (in each Softgel) (NIGHTTIME ONLY)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Purpose (DAYTIME ONLY)
Acetaminophen …………...... Pain reliever/fever reducer
Dextromethorphan HBr …... Cough suppressant
Phenylephrine HCl ………..... Nasal decongestant
Purpose (NIGHTTIME ONLY)
Acetaminophen ………….. Pain reliever/fever reducer
Dextromethorphan HBr …. Cough suppressant
Doxylamine succinate………. Antihistamine
Uses (DAYTIME ONLY)
temporarily relieves common cold/flu symptoms: • nasal
congestion • cough due to minor throat & bronchial irritation • sore
throat • headache • minor aches & pains • fever
Uses (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 ONLY)
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 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,
occurs with or is 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.
Ask a doctor before use if you have
• 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
Stop use and ask a doctor if
• 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.
Warnings (NIGHTTIME ONLY)
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 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,
occurs with or is 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.
• to make a child sleep
Ask a doctor before use if you have • 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
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin
When using thls product
• 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
Directions (DAYTIME ONLY)
- take only as directed (see Warnings)
- do not exceed 4 doses in 24 hrs
| adults and children 12 yrs & over | 2 softgels 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 (NIGHTTIME ONLY)
- take only as directed (see Warnings)
- do not exceed 4 doses in 24 hrs
| 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 |
•When using other Daytime or Nighttime products,
carefully read each label to ensure correct dosing
Other information (DAYTIME & NIGHTTIME)
- store at room temperature 20°-25°C (68°-77°F)
- avoid excessive heat
Inactive ingredients (DAYTIME ONLY)
FD&C Red #40 FD&C Yellow #6,
Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol,
Purified water, Sorbitol sorbitan solution, Titanium dioxide
Inactive ingredients (NIGHTTIME ONLY)
D&C yellow # 10, FD&C blue #1,
Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol,
Purified water, Sorbitol sorbitan solution, Titanium dioxide
Principal Display Package Label
Premier **COMPARE TO THE ACTIVE INGREDIENTS IN
Value® VICKS® DAYQUIL® AND VICKS® NYQUIL® LIQUICAPS®
Non-Drowsy Multi-Symptom
Daytime Nighttime
COLD/FLU RELIEF
Acetaminophen Acetaminophen/ Dextromethorphan HBr/
Dextromethorphan HBr/Phenylephrine HCl Doxylamine Succinate
• Aches, Fever & Sore Throat • Headache, Fever, Sore Throat, Minor Aches and Pains
• Nasal Congestion • Sneezing, Runny Nose
• Cough • Cough
Alcohol - Free
Antihistamine - Free
32 Softgels 16 Softgels
48 Total
Softgels
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED
**This product is not manufactured or distributed by Procter & Gamble, owner of the
registered trademark Vicks® DayQuil® LiquiCaps®.
**This product is not manufactured or distributed by Procter & Gamble, owner of
the registered trademark Vicks® NyQuil® LiquiCaps®.
Dlstribuled By: Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, Pa 19087
If for any reason you are not satisfied with
this product, please return it to the store
where purchased for a full refund.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTOIN FOR COMPLETE WARNINGS
AND PRODUCT INFORMATION.
BX-095
1
987495
1/20
res
| DAYTIME AND NIGHTTIME COLD/FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate kit |
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| Labeler - Pharmacy Value Alliance, LLC (101668460) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| AptaPharma Inc. | 790523323 | manufacture(68016-882) | |