Label: DAYTIME COLD AND FLU- acetaminophen, dextromethorphan hbr and phenylephrine hcl 325 mg, 10 mg and 5 mg capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 70005-003-02, 70005-003-25, 70005-003-50 - Packager: We Care Distributor Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 16, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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, lasts for more than 2 days, occurs with or is 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 monomine 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
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
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Directions
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take only as directed - see Liver warning
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do not exceed 6 doses per 24 hours
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adults and children 12 years and over: 2 softgels with water every 4 hours
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children 4 to under 12 years: ask a doctor
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children under 4 years: do not use
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when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
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- Other information
- Inactive ingredients
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Questions or comments?
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAYTIME COLD AND FLU
acetaminophen, dextromethorphan hbr and phenylephrine hcl 325 mg, 10 mg and 5 mg capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70005-003 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 5 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape OVAL Size 22mm Flavor Imprint Code SN;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70005-003-25 25 in 1 BOX 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:70005-003-50 50 in 1 BOX 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:70005-003-02 2 in 1 POUCH 3 2 in 1 POUCH; 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 02/15/2016 Labeler - We Care Distributor Inc. (079832998) Establishment Name Address ID/FEI Business Operations Softech Pharma Pvt. Ltd 677111277 manufacture(70005-003)
