NDC | 41520-270-24 |
Set ID | ba3e9c30-28b9-4604-8af8-00d1f2eed873 |
Category | HUMAN OTC DRUG LABEL |
Packager | American Sales Company |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each caplet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 8 caplets in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include ■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away.Do not use
■ 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 ■ with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other Information
- Inactive ingredients
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Package/Label Principal Display Panel
CareOne®
Compare to the active ingredient in Sudafed PE® PRESSURE + PAIN**
SINUS PRESSURE + PAIN PE
Pain Reliever - Acetaminophen
Nasal Decongestant - Phenylephrine HClMax Strength
Relieves:
Sinus Pain & Headache
Sinus Pressure
Nasal & Sinus CongestionDoes not contain pseudoephedrine
NON-DROWSY
24
COATED CAPLETS*
*Capsule - Shaped TabletsDISTRIBUTED BY FOODHOLD U.S.A., LLC
LANDOVER, MD 20785 1-877-846-9949
©2016 S&S Brands, LLC
Quality guaranteed or your money backLB0604
R0316**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark SUDAFED PE® PRESSURE + PAIN.
Care One Sinus Pressure + Pain PE
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INGREDIENTS AND APPEARANCE
SINUS HEADACHE PE NON- DROWSY MAXIMUM STRENGTH
acetaminophen and phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-270 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 17mm Flavor Imprint Code AZ270 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-270-24 24 in 1 BLISTER PACK; Type 0: Not a Combination Product 06/12/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 06/12/2014 Labeler - American Sales Company (809183973)