Label: SINUS PRESSURE AND PAIN- acetaminophen, phenylephrine hcl tablet
- NDC Code(s): 55319-702-08
- Packager: Family Dollar Services Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 4, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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 4,000 mg of acetaminophen in 24 hours
- 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
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- heart disease
- thyroid disease
- diabetes
- liver disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
FAMILY
Wellness™COMPARE TO THE
ACTIVE INGREDIENTS
IN SUDAFED PE® SINUS
PRESSURE + PAIN*MAXIMUM STRENGTH
SINUS
PRESSURE & PAINAcetaminophen
Phenylephrine HCl
Pain Reliever/Fever Reducer
Nasal DecongestantRELIEVES:
• Sinus Pressure & Congestion
• Sinus HeadachePseudoephedrine free
24 CAPLETS
NON
DROWSYACTUAL SIZE
NDC 55319-702-08
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING*This product is not manufactured or distributed by Kenvue Inc.,
owner of the registered trademark SUDAFED PE® SINUS
PRESSURE + PAIN.
50844 ORG082050208DISTRIBUTED BY: MIDWOOD BRANDS LLC,
500 VOLVO PKWY, CHESAPEAKE, VA 23320 USANOT 100% SATISFIED?
Return within 30 days to the store of purchase
for a refund (with receipt) or exchange.Family Wellness 44-502
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INGREDIENTS AND APPEARANCE
SINUS PRESSURE AND PAIN
acetaminophen, phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-702 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) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color orange Score no score Shape OVAL Size 18mm Flavor Imprint Code 44;502 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-702-08 2 in 1 CARTON 01/04/2024 1 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 Drug M012 01/04/2024 Labeler - Family Dollar Services Inc (024472631) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(55319-702) , pack(55319-702) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(55319-702)