Label: DOLEX FEM- acetaminophen, caffeine, pyrilamine maleate tablet, coated
- NDC Code(s): 55758-326-24
- Packager: Pharmadel LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Updated October 16, 2020
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- Active Ingredients
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 tablets 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.
Allergy warning: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
- skin reddening
- facial swelling
- asthma (wheezing)
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
When using this product
- you may get drowsy
- avoid alcoholic drinks
- excitability may occur, especially in children
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- limit the use of caffeine-containing medications, foods or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat. The recommended dose of this product contains aboout as much caffeine as a cup of coffee.
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of reach of children
- Other Information
- Inactive ingredients
- Questions or comments?
- Dolex Fem
INGREDIENTS AND APPEARANCE
acetaminophen, caffeine, pyrilamine maleate tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-326 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 60 mg PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 15 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color white Score no score Shape CAPSULE Size 17mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55758-326-24 1 in 1 CARTON 10/01/2020 1 24 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 10/01/2020 Labeler - Pharmadel LLC (030129680) Registrant - Pharmadel LLC (030129680) Establishment Name Address ID/FEI Business Operations Healthlife of USA LLC 079656178 manufacture(55758-326)