OTC Medication Information: Daytime Cold and Flu Relief

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)

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

Label
(click image for full-size original)

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
Packaging
# 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. (079721290)
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.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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