Indications and uses
temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever
Daytime and Nighttime Cold/Flu Relief
- Manufacturer
- Pharmacy Value Alliance, LLC | AptaPharma Inc.
- Effective date
- 2022-12-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:43:59
Label at a glance#
ProductDaytime and Nighttime Cold/Flu Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure15 sections
Dosage and administration
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
Contacts and useful links#
Label contents#
Full prescribing information#
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
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
OTC - WHEN USING SECTION
When using this product do not use more than directed
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison
Control Center right away. Quick medical attention is critical for adults as
well as children, even if you do not notice any signs or symptoms.
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.
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
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
OTC - STOP USE SECTION
Stop use and ask a doctor if
• pain or cough gets worse or lasls more than 7days
• 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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control
Center right away. Quick medical attention is critical for adults as well as
children, even if you do not notice any signs or symptoms.
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
Questions? (DAYTIME & NIGHTTIME)
Call weekdays from 9:30 AM to 4:30 PM EST at
1-877-798-5944
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
Products#
Every source-derived product name is available through these pages.
- Daytime and Nighttime Cold/Flu Relief
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
- Daytime Cold/Flu Relief
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- SORBITAN
- TITANIUM DIOXIDE
- Nighttime Cold/Flu Relief
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68016-882 | 68016-882-48 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 93fea484-953b-4bf1-8a3d-84f73c93be1a | 893cbb47-7926-467f-ab03-c1b4419bceeb | 2022-12-18 | Warnings | 93fea484-953b-4bf1-8a3d-84f73c93be1a 893cbb47-7926-467f-ab03-c1b4419bceeb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.