DAYTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled
A&Z Holistic Products, Inc.
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.
ACTIVE INGREDIENTS (IN EACH SOFTGEL)
Dextromethorphan HBr 10mg
Phenylephrine HCI 5mg
Pain reliever/fever reducer
temporarily relieves common cold and fly symptoms:
- nasal congestion
- cough due to minor throat and bronchial irritation
- sore throat
- minor aches and pains, fever
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
- 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.
- take only as directed (see
- 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
Children under 4 years
- store at room temperature
- do not use if blister is torn or open
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
*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® Dayquil® Cold & Flu Liquicaps
AZ Holistic Products, Inc.
Hauppauge, NY 11788
| DAYTIME COLD AND FLU RELIEF |
acetaminophen, dextromethorphan hbr, phenylephrine hci capsule, liquid filled
|Product Information |
|Product Type ||HUMAN OTC DRUG ||Item Code (Source) ||NDC:69619-303 |
|Route of Administration ||ORAL ||DEA Schedule || |
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|ACETAMINOPHEN (ACETAMINOPHEN) ||ACETAMINOPHEN ||325 mg |
|DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) ||DEXTROMETHORPHAN HYDROBROMIDE ||10 mg |
|PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) ||PHENYLEPHRINE HYDROCHLORIDE ||5 mg |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| GELATIN || |
| GLYCERIN || |
| FD&C RED NO. 40 || |
| POLYETHYLENE GLYCOL 400 || |
| POVIDONE || |
| PROPYLENE GLYCOL || |
| WATER || |
| SORBITOL || |
| FD&C YELLOW NO. 6 || |
|Product Characteristics |
|Color ||orange (amber) ||Score ||no score |
|Shape ||OVAL ||Size ||20mm |
|Flavor || ||Imprint Code ||534 |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:69619-303-10 ||1 BLISTER PACK in 1 BOX ||contains a BLISTER PACK |
| 1 || ||10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK ||This package is contained within the BOX (69619-303-10) |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|OTC monograph final ||part341 ||03/24/2016 || |
|Labeler — A&Z Holistic Products, Inc.
|Registrant — A&Z Holistic Products, Inc. (079721290) |
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|Anshi Pharmaceutical (Zhongshan) Inc. || ||528101821 ||manufacture (69619-303) |
Revised: 10/2019 A&Z Holistic Products, Inc.