Daytime Cold/Flu Relief Softgels
- Manufacturer
- Pharmacy Value Alliance, LLC | AptaPharma Inc.
- Effective date
- 2022-12-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:43:58
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
DRUG FACTS
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
OTC - PURPOSE SECTION
Purpose
Acetaminophen …………….….Pain reliever/fever reducer
Dextromethorphan HBr .....Cough suppressant
Phenylephrine HCI ............Nasal decongestant
INDICATIONS & USAGE SECTION
Uses temporarily relieves common cold/flu
symptoms: • nasal congestion • cough due to minor throat
& bronchial irritation • sore throat • headache
• minor aches & pains • fever
WARNINGS SECTION
Warnings 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, lasts 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.
OTC - ASK DOCTOR SECTION
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 as occurs with smoking, asthma, or
emphysema
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
OTC - WHEN USING SECTION
When using this productdo 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 accidental 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.
DOSAGE & ADMINISTRATION SECTION
Directions
• take only as recommended (see Warnings)
• do not exceed 4 doses per 24 hours
| adults & children 12 years & over | 2 softgel with water every 4 hours |
| 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 SAFETY INFORMATION
Other information
• Store at room temperature 20-25oC (68-77oF)
• avoid excessive heat
INACTIVE INGREDIENT SECTION
Inactive ingredients FD&C Red #40, FD&C Yellow #6,
gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol,
Purified water, Sorbitol sorbitan solution Titanium dioxide
OTC - QUESTIONS SECTION
Questions? Call weekdays from 9:30 am to 4:30 pm EST.
1-877-798-5944
Principal Display Package
Premier
Value®
*COMPARE TO THE ACTIVE INGREDIENTS
IN VICKS® DAYQUIL® LIQUICAPS®
Non-Drowsy
Daytime
COLD/FLU RELIEF
Acetaminophen / Dextromethorphan HBr / Phenylephrine HCl
• Aches, Fever & Sore Throat
• Nasal Congestion
• Cough
Alcohol - Free
Antihistamine - Free
16 Softgels
**This product is not manufactured or distributed by
Procter & Gamble, owner of the registered trademark
Vicks® DayQuil® LiquiCaps®.
Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, Pa 19087
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED
If for any reason you are not completely 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 CARTON FOR COMPLETE
WARNINGS AND PRODUCT
INFORMATION
BX-094
9
987542
1/20
res
Products#
Every source-derived product name is available through these pages.
- Daytime Cold/Flu Relief Softgels
- ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68016-880 | 68016-880-16, 68016-880-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
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 |
|---|---|---|---|---|---|---|
| 8aa3516a-2d47-42bf-a861-4854ec4e0777 | 4d268cf9-fd71-4e61-b874-790b123bd3a0 | 2022-12-18 | Warnings | 8aa3516a-2d47-42bf-a861-4854ec4e0777 4d268cf9-fd71-4e61-b874-790b123bd3a0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

