![DAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC]](https://medic.hrt.org//dailymed/images/41a4f519-0dca-4f38-8bb1-a9cace855d82/daytime-cold-and-flu-relief-1.jpg)
| NDC | 68016-199-16, 68016-199-24 |
| Set ID | 41a4f519-0dca-4f38-8bb1-a9cace855d82 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Chain Drug Consortium, LLC |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each softgel)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- 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 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
- diabetes
- heart disease
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- new symptoms occur
- nervousness, dizziness or sleeplessness occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- cough comes back, or occurs with rash or headache that lasts
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose can cause liver damage. 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 for children even if you do not notice any signs or symptoms.
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Directions
- do not take more than directed (see Overdose warning)
- do not take more than 4 doses in 24 hours
- adults and children 12 years and over: take 2 softgels with water every 4 hours
- swallow whole; do not crush, chew, or dissolve
- children under 12 years: do not use
- when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
**COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® DAYQUIL®
Non-Drowsy
Daytime
COLD/FLU RELIEF
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine HCl
Pain Reliever • Fever Reducer • Cough Suppressant • Nasal Decongestant
Softgels
**This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® LiquiCaps®.
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.
DISTRIBUTED BY: CHAIN DRUG CONSORTIUM, LLC.
3301 NW BOCA RATON BLVD. SUITE 101
BOCA RATON, FL 33431
- Product Label
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INGREDIENTS AND APPEARANCE
DAYTIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-199 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 21mm Flavor Imprint Code P19;95A;36A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-199-16 2 in 1 CARTON 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:68016-199-24 2 in 1 CARTON 2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 11/15/2012 Labeler - Chain Drug Consortium, LLC (101668460)
