Indications and uses
temporarily relieves common cold and fly symptoms: nasal congestion cough due to minor throat and bronchial irritation sore throat headache minor aches and pains, fever
Daytime Cold and Flu Relief
- Manufacturer
- A&Z Holistic Products, Inc. | Anshi Pharmaceutical (Zhongshan) Inc.
- Effective date
- 2019-10-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:08:44
Label at a glance#
ProductDaytime Cold and Flu Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
take only as directed (see Warnings ) do not exceed 4 doses per 24 hours Adults and children 12 years and over take 2 softgels with water every 4 hours Children 4 to under 12 years Ask a doctor Children under 4 years Do not use
Contacts and useful links#
Label contents#
Full prescribing information#
ACTIVE INGREDIENTS (IN EACH SOFTGEL)
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCI 5mg
PURPOSES
Pain reliever/fever reducer
Cough suppressant
Antihistamine
USES
temporarily relieves common cold and fly symptoms:
- nasal congestion
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains, fever
WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses in 24 hours, 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
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
- with any other product 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 drugs. If you do not know if your prescription 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 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
When Using this product
- do not exceed recommended dosage
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.
If pregnant or breast feeding
ask a health professional before use
Keep Out of Reach of Children
Overdose warning: In case of accidental overdose, contact a doctor or Poison Control Center immediately (1-800-222-1222). Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
DIRECTIONS
- take only as directed (see Warnings)
- do not exceed 4 doses per 24 hours
Adults and children 12 years and over
- take 2 softgels with water every 4 hours
Children 4 to under 12 years
- Ask a doctor
Children under 4 years
- Do not use
OTHER INFORMATION
- store at room temperature
- do not use if blister is torn or open
INACTIVE INGREDIENTS
FD&C Red #40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol, FD&C Yellow #6.
QUESTIONS OR COMMENTS?
Call toll free 1-844-374-0016
PRINCIPAL DISPLAY PANEL
Product Label
*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® Dayquil® Cold & Flu Liquicaps
Manufactured for:
AZ Holistic Products, Inc.
Hauppauge, NY 11788
Products#
Every source-derived product name is available through these pages.
- Daytime Cold and Flu Relief
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI
- GELATIN
- GLYCERIN
- FD&C RED NO. 40
- POLYETHYLENE GLYCOL 400
- POVIDONE
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- FD&C YELLOW NO. 6
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69619-303 | 69619-303-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
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 |
|---|---|---|---|---|---|---|
| e7265746-0e2c-c511-e053-2a95a90a5994 | f78fdf84-5ed2-49ce-bc9b-e31663bdc92a | 2022-08-26 | Warnings | f78fdf84-5ed2-49ce-bc9b-e31663bdc92a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.